ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stan
FDA device recall Z-1537-2017 · posted 2017-02-23 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may impact all analytes available on the ADVIA Centaur XPT System test menu.
- Action taken
- Siemens sent an Urgent Medical Device Correction letter ( UMDC) dated February 2, 2017. An Urgent Field Safety Notice letter ( UFSN) dated February 2017, was also sent to foreign customers. Customers must follow instructions in the UMDC and UFSN letters. For questions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (312) 275-7795.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- US: 17 units; Foreign: 712 units
- Distribution
- Worldwide distribution - US Distribution to the states of : NH, MD, MS, MN, IL, TX, CA and WA, and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Colo
- Date initiated
- 2017-02-02
- Date posted
- 2017-02-23
- Date terminated
- 2018-06-22
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVIA CENTAUR TSH (K141999) | Siemens Healthcare Diagnostics, Inc. | 2015-04-22 |