FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: 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).
- Recall number
- Z-0032-2012
- Recalling firm
- Philips Healthcare Inc.
- 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).
- Status
- Terminated
- Initiated
- 2011-09-01
- Posted
- 2011-10-07
- Terminated
- 2017-03-13
- Reason
- Clinical measurements on true size printouts may be inaccurate
- 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
- 20 units
- Distribution
- Worldwide Distribution: Nationwide distribution including Puerto Rico; and the countries of Argentina, Brazil, China, France, Greece, India, Israel Mexico, and Turkey.
- Lot, serial or model codes
- Sofware release R2.3 SP1
- 510(k) numbers
- ["K072960"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28