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Report A Y2K Problem

See Reports of Y2K Problems

 Archived Medical Device Y2K Problem Reports and Alerts

Based on worldwide experience, FDA is not aware of any deaths or serious injuries resulting from the Y2K problem and medical devices during the rollover into the Year 2000. Every facet of the healthcare sector contributed to this outstanding outcome.

With the approach of February 29, you should be prepared for the possibility of date-related problems associated with the leap year rollover. Because date-related problems could occur on or after February 29, 2000, we remind you to review your contingency plans and heighten your level of vigilance for possible problems during this time. You can check the Y2K (including leap year) status of computer-controlled devices by consulting FDA's Federal Y2K Biomedical Equipment Clearinghouse (Y2K Clearinghouse) at http://www.fda.gov/cdrh/yr2000/year2000.html. In addition, the Rx2000 Solutions Institute lists products with reported leap year problems on their web site at http://www.rx2000.org.

The Y2K Clearinghouse is a database established to provide healthcare facilities and device users with information on the Y2K compliance status of biomedical equipment. The Clearinghouse contains information or manufacturer web-site links for Y2K non-compliant products, and information on specific product models that are Y2K compliant. After February 29, 2000, we will continue to make the Y2K Clearinghouse available on the World Wide Web; however, we will no longer update the information contained there. The existing links to manufacturer's web sites, which have been provided to FDA, will continue to be listed, but some device manufacturers may in the future remove Y2K product status information from their linked web sites. If Y2K information for a specific product is not available through the Y2K Clearinghouse, users should contact the device manufacturer directly.

This page will be used for the special purpose of providing rapid distribution of information regarding potential Year 2000 or other date-related problems associated with medical devices during and immediately after the transition to the Year 2000. Information will be posted to this page when FDA concludes, following a brief initial investigation, that rapid dissemination of the information regarding a specific medical device to healthcare facilities and the public is warranted. It is anticipated that such information will be made available following rapid consultation with the manufacturer of the specific device whenever possible.

To receive e-mails for immediate notification of these reports, subscribe to our electronic mailing list at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/dev-alert/alert.cfm

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