Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.
FDA device recall Z-0563-03 · posted 2003-02-21 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Inc
- Reason for recall
- The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.
- Action taken
- The firm mailed a ''Customer Advisory Notice'' to all affected customers on 1/23/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 311 units
- Distribution
- The sytems were shipped to end-users located nationwide and worldwide.
- Date initiated
- 2003-01-23
- Date posted
- 2003-02-21
- Date terminated
- 2008-10-29
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL 3000 NUCLEAR CAMERA (K882312) | Ohio Imaging, Inc. | 1988-07-14 |