BrightView XCT Gamma Camera, 3/4". Philips Medical Systems, Inc. Intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall Z-2949-2011 · Posted 2011-08-04
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Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeKPS
Date Initiated2011-06-15
Date Terminated2013-02-15
Product Quantity213 units
Reason for Recall
Non-conformances with BrightView X/XCT systems running version 2.0.1 including data transfer, XCT acquisition, Pixel Mask for image reconstruction and table moving incorrectly.
Firm Action
Philips Medical Systems, Inc. set a "Customer Information" letter dated July 8, 2011 to all affected customers.
The letter informed them of an upcoming software updated (version 2.5).
For questions please contact 800-722-9377 (option 5).
Root Cause
Software design
Distribution Pattern
Worldwide Distribution: (USA) Nationwide distribution and the countries of Greece, Australia, Belgium, China, Czech Republic, France, Germany, Indonesia, Israel, Japan, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Slovakia, South Korea, Spain, Switzerland, Taiwan U.A.E., and the UK.
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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