Atellica CH 930 Analyzer (2021-05-06)
- Starting date:
- May 6, 2021
- Posting date:
- May 26, 2021
- 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-75661
Last updated: 2021-05-26
Affected Products
Atellica CH 930 Analyzer
Reason
Siemens Healthcare Diagnostics Inc. has confirmed that, as the lamp reaches end of life, there is apotential for the Photometer Lamp (SMN 11075676), used in the Atellica CH 930 Analyzer, to increasein intensity on one or more of the eleven wavelengths used in testing. This unexpected increase inintensity can drive the photometer into saturation and may cause erroneous unflagged photometrictest results.
Affected products
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