Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033. Indended use: X-Ray, Fluoroscopic
FDA device recall Z-0189-2010 · posted 2009-11-12 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- possible injury to hand/fingers
- Action taken
- Siemens Medical Solutions USA, Inc. issued a "Customer Safety Advisory Notice" dated September 11, 2009 to inform customers of the potential hazard to patients when using the Siregraph CF system. For further information, contact Siemens at 1-610-448-4500.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 14 units
- Distribution
- Nationwide Distribution -- FL, IL, MI, PA and TX.
- Date initiated
- 2009-09-23
- Date posted
- 2009-11-12
- Date terminated
- 2010-01-12
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIREGRAPH CF (K960266) | Siemens Medical Solutions USA, Inc. | 1996-03-11 |