EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW
FDA device recall Z-2053-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Inaccurate measurements when exporting radiography images to Picture Archiving and Communication System (PACS ).
- Action taken
- On 03/14/08 the firmed mailed certified letters to the customers of the device. The letter advises of the problem and stated that images exported from the Easy Vision RAD workstation should not be used for measurements. The letter also states that the firm will be performing upgrades of the devices. If you have questions, contact Sarah Baxter at 425-487-7665 or the Philips Call Center at 800-722-9377, #5, #2.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 401 units
- Distribution
- Products were distributed nationwide to 159 hospitals, 3 VA's and 12 Department of Defense accounts.
- Date initiated
- 2008-03-10
- Date posted
- 2008-09-16
- Date terminated
- 2010-09-28
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS EASYVISION (K963980) | Philips Medical Systems North America, Inc. | 1996-12-23 |
| PHILIPS EASYVISION (K920950) | Philips Medical Systems, Inc. | 1992-04-27 |