—#95212

Product

SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Systems (Cleveland), Cleveland OH. Intended to produce 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: 3/8" SPECT, Model number 4535 600 66661, and 5/8 SPECT, Model number 4535 602 20381, all units manufactured between July 2001 to August 2003.

Why it was recalled

Detector arm assembly may slide to hardware limit, potentially causing impact.

Root cause (FDA determination)

Component change control

Action the firm took

Firm will notify consignees via Urgent - Medical Device Correction, dated Nov 3, 2010, via FedEx. The letter identified the affected product, described the problem, the hazard involved, how to identify affected products, actions to be taken, and actions planned by Philips. Customers are to contact their Field Safety Engineer immediately to schedule an inspection of their system. If customers suspect that the identified problem has occurred with their device, they should immediately stop using the system until Philips has confirmed it as safe to use. If customers need further information concerning this issue, they are to contact their local Philips representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- USA and the Netherlands.

Timeline

Recall initiated: 2010-10-15
Posted by FDA: 2010-11-17
Terminated: 2012-03-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95212. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.