Class 2 Device Recall SKYLight

• Date Initiated by Firm: December 28, 2010
• Date Posted: March 04, 2011
• Recall Status: Terminated on April 02, 2012
• Recall Number: Z-1552-2011
• Recall Event ID: 57589
• 510(K)Number: K000908
• Product Classification: Emission Computed Tomography System - Product Code KPS
• Product: SKYLight, AZ 8 FT 3/8"; 8 FT, 5/8"; 9 FT 3/8"; and 9 FT 5/8". 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 882420; Model number (8 FT 3/8): 2161-3000B, 4535-602-46831; Serial numbers: 2000149 2000154 2000158 2000168 2000170 2000172 20007040128 K06010056 K06030067 K06010056 K06030067 2000146 2000152 2000155 2000156 2000161 2000162 2000163 2000164 2000166 2000169 2000173 2000174 2000176 2000181 2000182 2000183 2000185 2000186 2000187 2000188 2000191 20002080145 20006120113 20006120114 20007010115 20007010116 20007020117 20007020118 20007020120 20007020122 20007030123 20007030125 20007050130 20007050131 20007050132 20007050133 20007060134 20007060135 20007060136 20007070138 20007070140 20007080144 K04110001 K05010003 K05010004-1 K05010005 K05030007 K05030009 K05030010 K05030011 K05040012-1 K05040013 K05040014 K05040015 K05040016 K05050019 K05050020 K05060022 K05060023 K05060024 K05060026 K05060027 K05070028 K05070029 K05070032 K05080034 K05080036 K05080037 K05080038 K05090040 K05090043 K05090044 K05090045 K05100046 K05100047 K05100048 K05110029 K05110051 K05110052 K06010057 K06010058 K06010060 K06020062 K06020063 K06020064 K06020065 K06030003 K06030066 K06030068 K06040071 K06040073 K06040074 K06040075 K06040077 K06050078 K06050079 K06060080 K06060081 K06060082 K06070083 K06070084 K06070085 K06070086 K06080087 K06080088 K06080090 K06080091 K06080094 K06080095 K06080097 K06090099 K06090100 K06090103 K06100105 K06100106 K06100107 Model number (8 FT 5/8); 2160-3001B, 4535-602-55271;Serial numbers: K03020003 Model number (9 FT 3/8): 2161-3000B; 4535-602-46641; Serial numbers: K05060019 K05070022 K05060019 K05070022 K05060019 K05070022 K05060019 K05070022 20006120064 20007010065 20007010065 K05010004 K05020008 K05020009 K05040012 K05040013 K05050015 K05050016 K05060018 K05060020 K05070023 K05110029 K06010031 K06010031 K06070049 K06080051 K06080052 K06090053 K06090054 K06100055 K06100056 K06100058 Model number (9 FT 5/8): 2160-3001B. Serial numbers:
• Recalling Firm/ Manufacturer: Philips Medical Systems; 3860 N 1st St; San Jose CA 95134-1702
• 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: Other
• 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, all varieties
• Distribution: Worldwide Distribution
• 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 = KPS