Date Initiated by Firm | January 26, 2009 |
Date Posted | November 13, 2009 |
Recall Status1 |
Terminated 3 on November 24, 2009 |
Recall Number | Z-0260-2010 |
Recall Event ID |
53517 |
510(K)Number | K051170 |
Product Classification |
Emission computed tomography system - Product Code JAK
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Product | GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170. |
Code Information |
Catalog Numbers: 882390 and 882410; Model Numbers: 4535 679 75691 and 4535 679 71891; and Serial Numbers: 4190 and 4191. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Road Cleveland OH 44143-2131
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For Additional Information Contact | 440-483-7000 |
Manufacturer 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 Determined Cause 2 | 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 | 2 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JAK
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