Monitor Ceiling Suspension for Fluoroscopic and Angiographic X-Ray Systems.
FDA device recall Z-0097-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Sales & Service Region No. America
- Reason for recall
- The thumbscrew hinge pin on the monitor support arm could become loose allowing the monitor to fall.
- Action taken
- The firm issued a letter dated October 10, 2003 to all affected customers. The suspension will be upgraded by field service personnel starting October 24, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 570 units
- Distribution
- The firm distributes to hospitals and medical centers.
- Date initiated
- 2003-10-10
- Date posted
- 2004-07-20
- Date terminated
- 2006-02-13
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS INTEGRIS V3000 ROTATIONAL ANGIO FUNCTION (K923813) | Philips Medical Systems, Inc. | 1992-10-16 |
| PHILIPS DIAGNOST 96 (K912470) | Philips Medical Systems, Inc. | 1991-08-07 |