Medical Device Recall: Z-0032-2012

FDA Recalls dataset · Firm: Philips Healthcare Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2011-09-01 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0032-2012.

Recall Res Number
Z-0032-2012
Recalling Firm / Manufacturer
FEI Number
1218950
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2011-09-01
Date Posted
2011-10-07
Date Terminated
2017-03-13
Product Code
LLZ
Event Number
59853
Product Quantity
20 units
Product Description 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).

Reason for Recall Clinical measurements on true size printouts may be inaccurate

Action Details 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.

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

Code Information / Serial Numbers Sofware release R2.3 SP1

Related Establishments / Registrations

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

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