Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiograp
FDA device recall Z-1464-2012 · posted 2012-04-26 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Potential misdiagnosis due to improperly automatically stitched images, improper image ruler handling.
- Action taken
- The firm, Philips Healthcare Imaging, issued an "URGENT-FIELD SAFETY NOTICE" dated March 30, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions carefully and to not use the Philips Image Ruler for measurements. The firm plans to supply an Addendum to the Instructions For Use and a Philips Service Engineer will contact the customer as soon as the Field Action Kit is ready to be implemented. If you need any further information or support concerning this issue, please contact your local Philips representative or call 1-866-767-2822.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 606 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech. Rep, Denmark, Finland, France, Germany, Guadeloupe, India, Indon
- Date initiated
- 2012-04-03
- Date posted
- 2012-04-26
- Date terminated
- 2014-03-13
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BUCKY VISION (K982795) | Philips Medical Systems, Inc. | 1998-11-24 |