Koodinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.
FDA device recall Z-0166-2010 · posted 2009-11-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.
- Action taken
- The recalling firm issued a Customer Safety Advisory Notice dated July 1, 2009 to affected customers via Update Instructions AX025/09/S to inform customer of the potential issues and provide instructions to prevent occurrence. The firm also provided an addendum to User Manual. Direct questions about the recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 107 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-07-01
- Date posted
- 2009-11-10
- Date terminated
- 2010-01-12
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANGIOSTAR (K884912) | Siemens Medical Solutions USA, Inc. | 1989-02-16 |