GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additional
Check against the official notice below — it lists the full affected range.
GE Healthcare has identified a potential safety issue affecting Optima CL323i and Optima IGS 320 angiographic X-ray systems worldwide. The problem involves a non-recoverable loss of displayed imaging, meaning the monitor video can stop displaying without being able to recover the image. These systems are used to generate fluoroscopic and rotational imaging for patients ranging from newborns to geriatric patients. A total of 108 affected systems have been distributed across multiple U.S. states and numerous countries including Canada, Brazil, China, India, Germany, Russia, and others. The recall includes a detailed list of specific system serial numbers and lot codes.
The recall record does not specify any remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems .
Reason for recall: GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems . Distribution: Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon Martinique , Morocco, Poland, Republic of Moldova, Russia, Spain Thailand, Trinidad, Turkey, and Uzbekist Quantity: 108 Lot/code info: Mfg Lot or Serial # System ID 00000085795HL3 812265CL1 00000086408HL2 313343IN1 00000087377HL8 361888CRC 00000089316HL4 201541LAB1 00000091432HL5 615396CV1 00000092611HL3 910671CL323A 00000095315HL8 910671CL323B 00000096904HL8 337494CATH1 00000097546HL6 631654INNOVA 00000097777HL7 937592OPT 00000098434HL4 504568INNOVA41 00000098435HL1 702616RDL31 00000098828HL7 843339INNOVA2 00000098977HL2 202269INNOVA 00000099837HL7 520417OPT3100 00000101009HL9 308865KR31 00000101825HL8 216778LABC 00000112807HL3 517353CATH 00000115275HL0 407CCE323 00000116573HL7 509837SSCL1 00000117808HL6 GON4173729 00000118032HL2 812284IN31 00000118368HL0 318330INNOVA1 00000118712HL9 361788CL323 00000118714HL5 806358INNOVA 00000119286HL3 912384CL 00000119585HL8 GON4263188 00000120996HL4 GON4263188 00000121694HL4 229890CL 00000121719HL9 520GVHCATH 00000124905HL1 217443PUSAM323 00000124965HL5 941483CL1 00000126533HL9 702880CATH1 00000127011HL5 318704CATH2 00000110028HL8 DZ1605VA01 00000108050HL6 082416090051 00000112754HL7 082416230024 00000113435HL2 GON4217188 00000113700HL9 082416010027 00000113963HL3 082416090050 00000113977HL3 082416090047 00000116179HL3 082416090058 00000116903HL6 082416100086 00000117226HL1 082416090053 00000117334HL3 082416120042 00000117414HL3 GON4229674 00000117572HL8 GON4242594 00000119287HL1 082416090062 00000119871HL2 082416210033 00000120419HL7 082416190023 00000120578HL0 082416190021 00000120736HL4 082416090059 00000120847HL9 082416090064 00000120867HL7 082416100085 00000120982H
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.