Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System.
FDA device recall Z-1283-2012 · posted 2012-03-23 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Gmbh, DMC
- Reason for recall
- Underexposed image due to lag in switching between auxiliaries
- Action taken
- Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated February 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The firm provided a work around for customers to use until a software update can be installed. Customers should contact their local Philips representative for questions regarding this notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 88 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Germany, Indonesia, Malaysia, Saudi-Arabia, Singapore, and Thailand.
- Date initiated
- 2012-03-09
- Date posted
- 2012-03-23
- Date terminated
- 2013-05-23
- Location
- Hamburg, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS EASYDIAGNOST ELEVA (K031535) | Philips Medical Systems North America Co. | 2003-06-17 |