—#103870

Product

MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072960
Affected lot / code info: Sofware release R2.3 SP1

Why it was recalled

Clinical measurements on true size printouts may be inaccurate

Root cause (FDA determination)

Software design

Action the firm took

Philips Medical notified all affected customers with a "Field Safety Notice" dated August 2011. The letter provides instructions to the customer for how to avoid the problem. Customers are informed that until the software upgrade is recieved from Philip, do not use the true-size printing feature if the system is configured for more than one DICOM printer. Customers will be instructed that they will receive a software upgrade when it is available. For questions on this recall contact Philips representative at (800) 722-9377.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: Worldwide Distribution: Nationwide distribution including Puerto Rico; and the countries of Argentina, Brazil, China, France, Greece, India, Israel Mexico, and Turkey.

Timeline

Recall initiated: 2011-09-01
Posted by FDA: 2011-10-07
Terminated: 2017-03-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103870. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.