Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage: The Philips MultiDiagnost
FDA device recall Z-0936-2012 · posted 2012-02-02 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- The skin dose and skin dose rate values are calculated using an incorrect point of reference. Therefore, the AKR as displayed and stored in patient records is too low, although the dose as received by the patient is not affected.
- Action taken
- Philips Healthcare issued on January 9, 2012 a mandatory Field Safety Notice to all affected customers. The letter identified the affected product, problem description, hazard involved and actions that should be taken by the customer/user. The letter contains important information for the continued safe and proper use of the equipment. Customers were instructed to review the following information with all members of there staff and retain a copy with the equipment "Instruction for Use". For information or support concerning this notice contact your local Philips representative 866-767-2822.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 28 units (US)
- Distribution
- Worldwide Distribution - Nationwide Distribution (USA) including the states of AR, AZ, CA, CO, FL, IA, KS, LA, MI, MO, NC, NY, OH, PA, TX, VA, VT, WA and WV
- Date initiated
- 2012-01-09
- Date posted
- 2012-02-02
- Date terminated
- 2017-02-13
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIDIAGNOST ELEVA (K050151) | Philips Medical Systems North America, Inc. | 2005-02-09 |