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U.S. Department of Health and Human Services

Class 2 Device Recall SKYLight

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 Class 2 Recall
SKYLight
see related information
Date Posted March 04, 2011
Recall Status1 Terminated on April 02, 2012
Recall Number Z-1551-2011
Recall Event ID 57589
Premarket Notification
510(K) Number
K000908 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product 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.
Code Information Catalog number 882050; Model number (8 FT 3/8): 2161-3000A, Serial numbers: K03100064 K03100065 K04120121 K04120122 K03050033 K03080053 K03080054 K03090055 K03090056 K03090057 K03090058 K03090059 K03090060 K03100061 K03100062 K03100063 K04010069 K04010070 K04010074 K04020072 K04020073 K04020074 k04030076 K04030075 K04030077 K04030078 K04030080 K04040081 K04040082 K04040083 K04040084 K04050086 K04050087 K04050088 K04060089 K04060090 K04070099 K04080100 K04080101 K04080102 K04090103 K04090104 K04090105 K04090108 K04090109 K04100110 K04100111 K04100112 K04110113 K04110115 K04110116 K04110119 K04120120 K04120123 K04120124 K04120125 K04120126 K04120120 K04120120. Model number (9 FT 3/8); 2160-3000A; Serial Numbers: K03080136 K03090138 K03100140 K03100142 K03110143 K03110144 K03110145 K03110146 K03110147 K03120148 K04010150 K04010152 K04010153 K04030155 K04030157 K04030158 K04060166 K04060167 K04070168 K04070169 K04070170 K04080172 K04090178 K04100183 K04100186. Model number (8 FT 5/8): 2161-3001A; Serial numbers: K03020003. Model number (9FT 5/8): 2160-3001A. 11131
Recalling Firm/
Manufacturer
Philips Medical Systems
3860 N 1st St
San Jose, California 95134-1702
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Elizabeth McLain
608-288-6948
Manufacturer Reason
for Recall
Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action 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.
Distribution Worldwide Distribution
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) Database 510(K)s with Product Code = KPS and Original Applicant = ADAC LABORATORIES
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