MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Usage: The Philips MultiD
FDA device recall Z-0985-2012 · posted 2012-02-08 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low
- Action taken
- Philips Healthcare issued a mandatory Urgent Field Safety Noticedated October 3, 2011 to all affected customers. The letter identifies the affected product, problem description, hazard involved, action to be taken by customer/user and actions planned by Philips to correct the problem. The letter provide important information for the continued safe and proper use of the equipment. The letter instructs customers to review the following information with all members of their staff who need to be aware of the contents of this communication and retain a copy with the equipment Instruction for Use. For further information or support concerning this issue contact your local Philips representative at 866-767-2822.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 10 units (US)
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of CA, IL, OH, SD, TX, WY and the countries of: Australia, Austria, Canada, Egypt, Germany, mexico, Turkey and UK
- Date initiated
- 2012-01-09
- Date posted
- 2012-02-08
- Date terminated
- 2017-02-13
- Location
- Andover, MA
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 |