Philips MultiDiagnost Eleva II Software Version R4.1.x Model: 708032 This Philips MultiDiagnost Eleva system is intended
FDA device recall Z-1196-2012 · posted 2012-03-09 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems Nederlands
- Reason for recall
- Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
- Action taken
- Philips Healthcare issued Urgent Field Safety Notices dated February 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. No action is necessary by the customer/user. A mandatory Field Safety Correction (FCO) Action will be issued to solve the problem. The FCO will consists of a Software update. For further support customers were instructed to contact their Phillips representative. For questions regarding this recall call 978-687-1501.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 14 units US; 25 units International
- Distribution
- Worldwide Distribution - USA (nationwide) and the following countries: Canada, Australia Austria Belgium Bahrain Czech Republic Denmark Estonia France Finland Germany Hong Kong Israel Italy Latvia Lux
- Date initiated
- 2012-02-24
- Date posted
- 2012-03-09
- Date terminated
- 2013-03-26
- Location
- Best, Netherlands
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS MULTIDIAGNOST ELEVA (K023441) | Philips Medical Systems | 2002-10-30 |