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Terminated

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.

FDA Recall Z-0412-2011 · Posted 2010-11-18

Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeLLZ
Date Initiated2009-01-30
Date Terminated2010-11-19
Product Quantity11 units in US

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution including DC, FL, MI, MO, NM, NY, OH, AND TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063093SECTRA WORKSTATION, VERSION 11.1Sectra Imtec AB · 2006-11-07K051315MODIFICATION TO: SECTRA IDS5 WORKSTATIONSectra Imtec AB · 2005-06-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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