FDA (Device enforcement)

11,102 recalls · page 83 of 112

• SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Inten2022-03-07
• syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.2022-03-07
• syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.2022-03-07
• syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.2022-03-07
• Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,2022-03-07
• GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier E2022-03-04
• Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.2022-03-04
• Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria2022-03-03
• DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.2022-03-03
• DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.2022-03-03
• DeRoyal DEXMED ACCESS CENTER TRAY, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.2022-03-03
• Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots2022-03-03
• Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots2022-03-03
• Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots2022-03-03
• ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots2022-03-03
• ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots2022-03-03
• ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots2022-03-03
• EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.2022-03-03
• EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.2022-03-03
• EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.2022-03-03
• EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.2022-03-03
• VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 4804222022-03-03
• DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 4804402022-03-03
• Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.2022-03-02
• FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.2022-03-01
• FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM102022-03-01
• Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)2022-02-28
• Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site2022-02-28
• MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x "My Therapy" P2022-02-28
• ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.2022-02-25
• Mycoplasma genitalium Control Panel (Inactivated Pellet)2022-02-25
• MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C44842022-02-25
• Surgicare Neuro Pack - Neurological Kit2022-02-25
• Anterior Hip Pack - Surgical Kit2022-02-25
• Coryell Memorial Hosp Total, Joint Pack - Surgical Kit2022-02-25
• Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.2022-02-25
• Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 113276002022-02-25
• Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 113277002022-02-25
• Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 108490002022-02-25
• syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 113277002022-02-25
• SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.2022-02-24
• SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.2022-02-24
• (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, Storz Scope, Catalog #82022-02-23
• Artis zee floor, Model Number 100941352022-02-23
• Artis zee ceiling, Model Number 100941372022-02-23
• Artis zee multi-purpose, Model Number 100941392022-02-23
• Artis zee biplane, Model Number 100941412022-02-23
• Artis zee floor MN, Model Number 100941422022-02-23
• Artis zee biplane MN, Model Number 100941432022-02-23
• Artis zeego, Model Number 102809592022-02-23
• Artis Q floor, Model Number 108482802022-02-23
• Artis Q ceiling, Model Number 108482812022-02-23
• Artis Q biplane, Model Number 108482822022-02-23
• Artis Q zeego, Model Number 108482832022-02-23
• Artis Q.zen floor, Model Number 108483532022-02-23
• Artis Q.zen ceiling, Model Number 108483542022-02-23
• Artis Q.zen biplane, Model Number 108483552022-02-23
• Illumina NextSeq 550Dx, REF: 20005715, CE, IVD2022-02-22
• ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Refurbished) 3. ACL TOP 350 CTS 00000280065 4. ACL TOP 500 CTS 00000280040 5. ACL TOP 500 CTS 00000280040R ( Refurbished) 6/ 6. ACL TOP 550 CTS 00000280045 7. ACL TOP 970 C2022-02-22
• IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]2022-02-22
• Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.2022-02-22
• I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 8222022-02-22
• Procedure Tray Catalog 10652022-02-22
• Cervical Tray Catalog 10892022-02-22
• Lumbar Tray Catalog 10912022-02-22
• Single Shot Epidural Tray Catalog 11652022-02-22
• Single Shot Epidural Tray Catalog 12922022-02-22
• Universal Tray Catalog 15672022-02-22
• Epidural Tray Catalog 15772022-02-22
• Port Tray Catalog 76072022-02-22
• I.V. Start Kit Catalog 81722022-02-22
• Nerve Block Tray Catalog Number: 84152022-02-22
• Single Shot Epidural Tray Catalog Number: 84172022-02-22
• Nerve Block Tray Catalog Number: 93422022-02-22
• Universal Nerve Block Tray Catalog Number: 97792022-02-22
• Universal Nerve Block Tray Catalog Number: 98182022-02-22
• MBB Tray Catalog Number: 98822022-02-22
• Pain Tray Catalog Number: 98832022-02-22
• CVC Dressing Change Kit Catalog Number: 2491R12022-02-22
• Nerve Block Tray Catalog Number: 3764R22022-02-22
• Cervical Tray Catalog Number: 3765R22022-02-22
• Single Shot Epidural Tray Catalog Number: 6183R12022-02-22
• Sterile Epidural Tray Catalog Number: 6259R22022-02-22
• Nerve Block Tray Catalog Number: 6796R32022-02-22
• Single Shot Epidural Tray Catalog Number: 6797R22022-02-22
• Pump Refill Kit Catalog Number: 7347R12022-02-22
• Single Shot Epidural Tray - 18G Catalog Number: 8139R22022-02-22
• Joint Injection Tray Catalog Number: 8561R12022-02-22
• Core Biopsy Tray Catalog Number: 8673R42022-02-22
• Bone Marrow Biopsy Tray Catalog Number: 8917R12022-02-22
• 3.2MM Pellet Insertion Tray Catalog Number: B11442022-02-22
• "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B13512022-02-22
• SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R12022-02-22
• SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R12022-02-22
• SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R12022-02-22
• SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R12022-02-22
• SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B15472022-02-22
• SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B15552022-02-22
• Female SS 3.5MM Pellet Insertion Tray Catalog Number: B15682022-02-22
• 3.2MM Pellet Insertion Tray Catalog Number: B7345R12022-02-22