510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-0261-2010

GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model...

Philips North America LLC / initiated 2009-01-26 / Terminated
FDA source (opens on fda.gov)

Philips Medical Systems (Cleveland) Inc began a recall of GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and... on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0261-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and 4535-674 41711, 510(k) #K052640
Product code
JAK System, X-Ray, Tomography, Computed
Reason for recall
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.
FDA root cause
Process change control
Action
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.
Quantity in commerce
9 units
Distribution
The recalled products were distributed to customers in the following states within the U. S.: OH, GA, MI, and CA and to customers overseas in: Germany, France Japan, and South Korea.
Product codes and lots
Catalog Numbers: 882470, 882471, and 882473; Model Numbers: 4535 679 83931 , 4525 679 94741, and 4535 674 41711; and Serial Numbers: 7096, 7139, 7144, 7145, 7146, 7148, 7149, 7150, and 7151.