Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.

FDA device recall Z-2059-2013 · posted 2013-08-26 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

Reason for recall

The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system.

Action taken

Philips Healthcare sent an Urgent Field Safety Notice letter dated July 24, 2013, to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed : When reading an image, a physician should not use the mirror icon for image side interpretation. 2. Clinical staff should follow the Instructions for Use and use lead letters to indicate body orientation of patient or equivalent electronic markers to provide Left/Right indications, during all X-ray image acquisitions. Philips will upgrade the system, which involves software and hardware upgrades of the system. The software provides a replacement icon that reduces the risk of the potential misinterpretation of the original mirror icon. Philips will also provide updated Instructions for Use for the work spot and the system (including an addendum). If you need any further information or support concerning this, please contact your local Philips representative Technical Support Line at 1-800-722-9377. We apologize for any inconvenience this may cause and trust that this information is adequately addressing any concerns you may have.

Root cause

Software design

Status

Terminated

Product code

KPR

Quantity affected

89

Distribution

Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DE, FL, GA, MO, MS, NC, NH, NY, PA and TX., and the countries of Canada, Australia, China, Czech Republic, France, Germany, G

Date initiated

2013-08-08

Date posted

2013-08-26

Date terminated

2020-09-03

Location

Andover, MA

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