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 Recall Z-0032-2012 · Posted 2011-10-07
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Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-09-01
Date Terminated2017-03-13
Product Quantity20 units
Reason for Recall
Clinical measurements on true size printouts may be inaccurate
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution: Nationwide distribution including Puerto Rico; and the countries of Argentina, Brazil, China, France, Greece, India, Israel Mexico, and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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