Health product recall

Atellica IM 1300/1600 Analyzers (2019-03-12)

Starting date:
March 12, 2019
Posting date:
March 28, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69432

Affected Products

  • A. Atellica IM 1300 Analyzer
  • B. Atellica IM 1600 Analyzer

Reason

Siemens Healthcare Diagnostics is informing customers of the following two (2) issues that have been identified with Atellica Solution products, which are installed with Atellica Solution software (SW) versions v1.17SP2 (SMN 11469659) or lower:

  1. For specific configurations of the Atellica Solution, the back cover on the Atellica Magline Transport for the Atellica CH 930 Analyzer, IM 1300 Analyzer, and IM 1600 Analyzer may not be detected as being open when the cover is open or removed.
  2. Scanning new versions of IM test definitions (TDEF) resets the customer defined settings to default values in the TDEF.

Affected products

A. Atellica IM 1300 Analyzer

Lot or serial number

IM00425

Model or catalog number

11066001

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES

B. Atellica IM 1600 Analyzer

Lot or serial number

IH00244
IH00255
IH00259

Model or catalog number

11066000

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES