Z-0412-2011

Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for...

Name: Z-0412-2011 Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2009-01-30
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2009-01-30 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for the manipulation and display of medical images... on 2009-01-30. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0412-2011
Status: Terminated
Initiated: 2009-01-30
Posted: 2010-11-18
Terminated: 2010-11-19
Recalling firm: Philips North America LLC
Product: Philips EasyVision MM workstation with software R10.2 and R11.1 The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. Device options enable mammography reading, teleradiology, fast demonstration, 3D, etc. Device accessories enable orthopedic pre-operative planning; angiography/cardiology imaging capabilities; and bone densitometry capabilities. Typical users are trained professionals such as physicians, radiologists, nurses, medical technicians and assistants.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Other
Action: 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.
Quantity in commerce: 11 units in US
Distribution: Nationwide Distribution including DC, FL, MI, MO, NM, NY, OH, AND TX
Product codes and lots: Site Numbers: 50310, 84026, 103216, 105518, 505284, 505973, 506122, 533261, 536204, 537203, and 557450.

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)