Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and 3.1 Model: 706034 Product Usage: Radi
FDA device recall Z-1216-2012 · posted 2012-03-15 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Misinterpretation of Mirror Icon-Mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system
- Action taken
- Philips Healthcare sent an Urgent Medical Device Correction letter dated February 8, 2012 to all affected customers. The letter identified the affected product, problem description, hazard involved, actions to be taken by customer/user and actions planned by Philips. The letter contains important information for continue safe and proper use of the equipment. Philips will contact customers to schedule the installation of the updated software. For further information or support contact your local Philips representative at the Technical Support Line 866-767-2822.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 60 units
- Distribution
- Worldwide Distribution - USA Nationwide
- Date initiated
- 2012-02-14
- Date posted
- 2012-03-15
- Date terminated
- 2020-09-23
- 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 |