Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
FDA device recall Z-1821-2012 · posted 2012-06-18 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally, the measurement tool is not used to check the ruler, or is used in the right way (ie: calibration), such calibration error is not detected. As a result of this, a surgical intervention may be execut
- Action taken
- Philips sent an Urgent - Field Safety Notice letter dated May 11, 2012 to their affected customers. The letter identified the affected product, what the issues are, under what circumstances they may occur and the actions to be taken to avoid or minimize the occurrence of the issue Philips plans to supply an Addendum to the Instruction for Use. A Philips Service Engineer will contact the affected customers as soon as the Field Action Kit is ready to be implemented. For questions contact your local Philips representative: Technical Support Line 1-800-722-9377.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IXR
- Quantity affected
- 6
- Distribution
- 6 US customers
- Date initiated
- 2012-05-11
- Date posted
- 2012-06-18
- Date terminated
- 2016-10-06
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS EASYDIAGNOST ELEVA (K031535) | Philips Medical Systems North America Co. | 2003-06-17 |
| PHILIPS EASY DIAGNOST (K970640) | Philips Medical Systems North America, Inc. | 1997-03-21 |