Device Recall GEMINI PET/CT diagnostic imaging systems 의 리콜

Recall

53517

Class 2

Z-0261-2010

2009-01-26

2009-11-13

Terminated

United States

2009-11-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85709

Upper patient pallet component of the recalling firm's gemini pet/ct system may be thinner than normally required which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight.

The firm notified customers with an "URGENT - Field Safety Notice" which was sent to the user/customers via FedEx on 1/26/2009. The letter informs customers of this potential safety hazard; the actions to be taken by the user/customer in order to mitigate risk to patients while undergoing scans; and the actions planned by Philips Medical's Service Engineers in order to correct the problem. The notification refers the user/customers to the applicable sections of their Systems Operations and Systems Information Manuals for a review on procedures for safely loading; unloading; and monitoring patients before, during, and after scanning studies. The notice goes on to inform the customers that replacement parts for the upper patient pallet(s) are on order and that a Philips Healthcare Field Service Engineer will be visiting each customer site within two (2) months in order to replace each affected pallet. Lastly, the notification provides a toll-free telephone number and instructions which the customer can use to contact a local Philips representative if additional information, or assistance is required. The firm's Customer Care Center contact is 1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology.