—#104250

Product

SKYLight Gamma Camera System; SKYLIGHT 8FT, 5/8" 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 product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K000908
Affected lot / code info: Model number: 2161-3001A

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems
Address: 3860 N 1st St, San Jose, California 95134-1702

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico.

Timeline

Recall initiated: 2011-09-27
Posted by FDA: 2011-11-19
Terminated: 2012-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104250. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.