Health product recall

ATELLICA (2020-12-08)

Starting date:
December 8, 2020
Posting date:
December 24, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74639

Last updated:
2020-12-24

Affected Products 

A. ATELLICA IM 1300 ANALYZER

B. ATELLICA IM 1600 ANALYZER

C. Atellica CH 930 Analyzer

Reason

Siemens Healthcare Diagnostics has identified the following issues with the atellica im 1300/1600 and atellica ch 930 analyzers, which are installed with atellica solution software (sw) versions v1.23.2 or lower. 

Affected products

A. ATELLICA IM 1300 ANALYZER

Lot or serial number

IM00425
IM00882
IM00952
IM00987
IRM008782003
IRM008822003
IRM008852003
IRM009022004

Model or catalog number

11066001

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

UNITED STATES

B. ATELLICA IM 1600 ANALYZER

Lot or serial number

IH00244
IH00255
IH00259
IH01519
IH01520
IRH008672002

Model or catalog number

11066000

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

UNITED STATES

C. Atellica CH 930 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

11067000

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

UNITED STATES