Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Op
FDA device recall Z-1353-06 · posted 2006-08-03 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Potential for measurements, lines, texts, etc to be stored incorrectly.
- Action taken
- On 7/1/06 the firm issued a letter to consignees stating the problem and how to prevent the problem. The firm reports a software update will be issued no later than September 2006 to correct the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 157 devices
- Distribution
- Nationwide.
- Date initiated
- 2006-07-01
- Date posted
- 2006-08-03
- Date terminated
- 2008-05-21
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1 (K033088) | Sectra AB | 2003-10-29 |