Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems; Part Number
FDA device recall Z-2196-2008 · posted 2008-06-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result.
- Action taken
- On June 25, 2008 all consignees were notified via written letter and on-site visit by the firm's sales representative, informing them that the switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result and providing instructions on the recall. A new software version will be provided. For assistance contact Siemens at 1-925-246-8407.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPQ
- Quantity affected
- 300 units
- Distribution
- Worldwide and Nationwide
- Date initiated
- 2008-03-10
- Date posted
- 2008-06-28
- Date terminated
- 2010-12-22
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIMVIEW 3000 CT OPTION (K953233) | Siemens Medical Solutions USA, Inc. | 1996-11-29 |
| SIMVIEW(TM) 3000 (K946053) | Siemens Medical Solutions USA, Inc. | 1995-03-31 |