Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for the manipu
FDA device recall Z-0412-2011 · posted 2010-11-18 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Review by firm of Philips EasyVision MM workstations found that to assure compliance with 21 CFR 900.12(c)(5) corrected software was needed so that all sites are in compliance.
- Action taken
- Philips Medical Systems North America Co. sent an URGENT-Field Safety Notice dated January 30, 2009, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were advised to ascertain the quality of a hard or soft copy explicity before further distribution to make sure that no part of the tissue is covered by image identification information. Philips will issue the Field Change Order (FCO) 83000129 and release a level on EasyVision MM R10.2 L6 and EasyVision MM R11.1 L3 to resolve the issue. Customers could contact Philips Healthcare Call Center at 1-800-722-9377, #2, #3 and Reference FCO 83000129 for any questions.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 11 units in US
- Distribution
- Nationwide Distribution including DC, FL, MI, MO, NM, NY, OH, AND TX
- Date initiated
- 2009-01-30
- Date posted
- 2010-11-18
- Date terminated
- 2010-11-19
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SECTRA WORKSTATION, VERSION 11.1 (K063093) | Sectra Imtec AB | 2006-11-07 |
| MODIFICATION TO: SECTRA IDS5 WORKSTATION (K051315) | Sectra Imtec AB | 2005-06-15 |