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.
Recall
- Recall Number
- Z-0398-2011
- Event Number
- 57029
- Firm
- Philips Medical Systems
- FEI Number
- 1525965
- Product Code
- KPS
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- October 15, 2010
- Posted
- November 17, 2010
- Terminated
- March 21, 2012
- Address
- 3860 N 1st St, San Jose, CA, 95134-1702
Description
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.
Detector arm assembly may slide to hardware limit, potentially causing impact.
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.
Worldwide Distribution -- USA and the Netherlands.
24 units