BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454
FDA Recall Z-0450-2015 · Posted 2014-12-01
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeKPS
Date Initiated2014-11-04
Date Terminated2018-07-02
Product Quantity85
Reason for Recall
Software issues
Firm Action
Philips Healthcare sent an URGENT - Field Safety Notice Medical Device Correction letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
This Field Safety Notice 88200485 is intended to inform you about:
" what the issues are and under what circumstances they can occur
" the actions that should be taken by the customer / user in order to prevent risks for patients or users
" the actions planned by Philips to correct these issues.
If you need any further information or support concerning these issues, please contact your local Philips representative:
For North America contact the Customer Care Solutions Center (1-800-722-9377: follow the prompts).
Philips apologizes for any inconveniences caused by this problem.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA including the states of AR, CA, FL, GA, ID, LA, ME, MI, MN, MO, MS, NJ, NY, OH, OK, PA, and TX. Government Facilities: AR, FL, MN, OH, and OK. and the countries of: Canada, China, Denmark, Germany, Italy, South Korea, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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