FDA Recall Database

Key Words
FDA - U.S Food and Drug Association.
CDRH - Center for Devices and Radiological Health
CDRH Recall Database - This database contains a list of classified medical device recalls since November 1, 2002

What is a "RECALL" ?
A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

URL for CDRH Database Search engine
http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm


What Can you find in CDRH Database.

• You can find recalls for many Medical imaging and medical systems. For example, PACS, MRI, US, FLuroscopy, etc...
• you will be able to see Reason for Recall, Action taken, Class of Recall.
• i.e, Recall for GE centricity RA1000 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=70808
  
  

Class of Recall

Class I	High risk
Class II	Less serious risk
Class III	Low risk

Examples of PACS Recalls

New Search Export to Excel Help Product Name Recall Class Date Posted Recalling Firm Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.... 2 Sep-18-2008 Philips Healthcare Informatics, Inc. WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs), used in the ... 2 Sep-11-2008 AGFA Corp. IMPAX® 4.1, IMPAX ® 4.5, IMPAX ® 5.0, IMPAX ® 5.1 IMPAX ® 5.2, IMPAX ® 6.0, IMPAX ® 6.2; Picture Arc... 2 Sep-11-2008 AGFA Corp. Impax® 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 an... 3 Sep-04-2008 AGFA Corp. GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT So... 2 Sep-02-2008 GE Healthcare Integrated IT Solutions Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 -... 2 Aug-16-2008 Philips Healthcare Informatics, Inc. Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 -... 2 Aug-16-2008 Philips Healthcare Informatics, Inc. Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Vox... 2 Jul-02-2008 AGFA Corp. iSite PACS image management system; Picture Archiving and Communications System; Radiology software ... 2 May-08-2008 Philips Healthcare Informatics, Inc. GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT So... 2 May-01-2008 GE Healthcare Integrated IT Solutions

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