||March 04, 2011
||Terminated on April 02, 2012
|Recall Event ID
System, Tomography, Computed, Emission - Product Code KPS
||SKYLight 8 FT 3/8" SPECT; 9 FT 3/8", SPECT; 8 FT, 5/8" SPECT; and 9 FT 5/8" SPECT.
Philips Medical Systems
Intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
||Catalog number 882050;
Model number (8 FT 3/8): 2161-3000A, Serial numbers:
Model number (9 FT 3/8); 2160-3000A; Serial Numbers:
Model number (8 FT 5/8): 2161-3001A; Serial numbers:
Model number (9FT 5/8): 2160-3001A.
|Philips Medical Systems
3860 N 1st St
San Jose, California 95134-1702
|For Additional Information Contact
|Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.
||Urgent - Medical Device Correction notifications were sent to all domestic consignees on December 28, 2010 via Federal Express. The letter identified the affected products, the reason for the recall, the hazard involved, and actions to be taken by the customer/user. Customers have been instructed to immediately stop using the system and contact a Philips service representative for an immediate inspection if one of the listed reasons apply. Customers were also instructed to follow the instructions in the system's Instructions For Use to avoid a collision or force on the detector. The firm's service will contact customers to arrange a time for Philips to conduct an inspection and to conduct the appropriate field safety correction. The letter should be placed in customers' Instructions For use. Notices to international consignees will be sent as soon as translation is complete. If customers need further information or support concerning this issue, they should contact their local Philips representative.
|Quantity in Commerce
||540 units total, all varieties.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES