SKYLight Gamma Camera System; SKYLIGHT 8FT, 3/8" SPECT Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Road, Cleveland, OH 44143. The SKYLight Gamma Camera System is intended to product images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall Z-0247-2012 · Posted 2011-11-19
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Recalling FirmPhilips Medical Systems
Recall StatusTerminated
Product CodeKPS
Date Initiated2011-09-27
Date Terminated2012-12-21
Product Quantity658 - all units in recall
Reason for Recall
A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
Firm Action
Philips Medical Systems sent a "Customer Information" letter dated September 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter lists additional precautions the customers should use while operating the device. Philips will notify customers for replacing the affected product through an Action for Performance-Proactive Field Change Order to resolve the issue. Contact Philips Customer Care Solutions at 1-800-722-9377, option 5, for questions concerning this notice.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution-USA (nationwide) including Puerto Rico.
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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