Z-0032-2012

MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used...

Name: Z-0032-2012 MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used...
Creator: Philips Healthcare Inc.
Published: 2011-09-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2011-09-01 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing... on 2011-09-01. The reason FDA records is "Clinical measurements on true size printouts may be inaccurate". 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-0032-2012
Status: Terminated
Initiated: 2011-09-01
Posted: 2011-10-07
Terminated: 2017-03-13
Recalling firm: Philips North America LLC
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).
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Clinical measurements on true size printouts may be inaccurate
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution: Nationwide distribution including Puerto Rico; and the countries of Argentina, Brazil, China, France, Greece, India, Israel Mexico, and Turkey.
Product codes and lots: Sofware release R2.3 SP1

Product code LLZ

K072960Class IICdp 5000, Media and Distribution Center, DiagnetCdp, Ltd. / cleared 2007-11-08

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)