MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Di
FDA device recall Z-1990-2014 · posted 2014-07-02 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.
- Action taken
- Urgent Medical Device Recall notification letter was sent to all affected US customers on June 2nd by Federal Express. OUS notifications were also sent to regional Siemens organizations who distributed in-country notifications and relevant notifications.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- LRG
- Quantity affected
- WA40: 560 US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired.
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Algeria Argentina Brazil Canada China Chile Columbia France Indonesia Libya Georgia Germany India Italy Japan Kazakhstan Lithuania Oman Pak
- Date initiated
- 2014-06-02
- Date posted
- 2014-07-02
- Date terminated
- 2015-12-23
- Location
- West Sacramento, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WALKAWAY TM 40 (K911400) | Baxter Healthcare Corp | 1991-11-19 |