BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 3/8" tilt, model number 4535604 34811, 3/4"tilt, model number 4535674 34801, and 3/8" fixed, model number 4535604 34781, all catalog number 882480 Medical device-- intended to produce images depicting anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall Z-1892-2009 · Posted 2009-09-16
Recalling FirmPhillips Nuclear Medicine
Recall StatusTerminated
Product CodeKPS
Date Initiated2009-07-02
Date Terminated2010-04-12
Product Quantity288 units
Reason for Recall
Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.
Firm Action
Firm initiated its recall notification on July 6, 2009 issuing a field safety notice to its consignees via FedEx and internationally through its personnel. Responses will be tracked for effectiveness. Questions may be directed to Philips Customer Care Center at 1.800.722.9377.
Root Cause
Process control
Distribution Pattern
Worldwide
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.