Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

Is my product affected?

Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

• UPC 00630414007960

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics is recalling the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer with software versions V1.19.0 and V1.19.2 due to issues with scanning new reagent lot test definitions. A total of 88 units were distributed, with 54 in the United States and 34 internationally across countries including Argentina, Australia, Belgium, Brazil, France, Germany, Italy, Japan, Mexico, Spain, Switzerland, and the United Kingdom, among others.

The recall record does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

Details from the source

Reason for recall: Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2 Distribution: Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam Quantity: 88 total US: 54;OUS 34 Lot/code info: (SW) version V1.19.0 and V1.19.2 UDI: 00630414007960

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 110660002019-08-15
• Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.2019-08-14
• Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defin2019-08-12
• da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.2019-08-19
• Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 1787312019-08-21

All FDA (Device enforcement) recalls