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U.S. Department of Health and Human Services

Class 2 Device Recall Precedence SPECT/CT System Upper Patient Pallet

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  Class 2 Device Recall Precedence SPECT/CT System Upper Patient Pallet see related information
Date Initiated by Firm January 26, 2009
Date Posted January 12, 2011
Recall Status1 Terminated 3 on January 13, 2011
Recall Number Z-0897-2011
Recall Event ID 51274
510(K)Number K051351  
Product Classification Table, powered - Product Code INQ
Product Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system,

Model Number: 4535 602 50851, Catalog Number: 882350,

Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH

Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.
Code Information Serial Numbers: 3000037, 3000048
Recalling Firm/
Manufacturer		 Phillips Nuclear Medicine
540 Alder Dr Bldg 4
Milpitas CA 95035-7443
For Additional Information Contact
408-321-9100
Manufacturer Reason
for Recall		 A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were to happens, could pose a risk to patient.
FDA Determined
Cause 2		 Process change control
Action The firm, Philips Healthcare, sent an "Urgent - Field Safety Notice" dated January 26, 2009 to all consignees/customers. The notice described the product, problem and action to be taken by customers and by Philips. The customers were instructed to reference their system's System Operation and System information Manuals regarding loading and unloading of patient; monitoring the patient during a study ,and careful monitoring during unsupported (cantilevered) table translation. Philips has ordered replacement parts and they will have a Philip Healthcare Field Service Engineer contact and visit the customers site within two months to replace the affected upper patient pallet. If you need any further information or support concerning this issue, please contact your local Philips representative at: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: and Oncology or your local Philips Healthcare office.
Quantity in Commerce 2 units
Distribution International distribution only: Mexico and Saudi Arabia.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = INQ and Original Applicant = ADAC LABORATORIES
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