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U.S. Department of Health and Human Services

Class 2 Device Recall SKYLight

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 Class 2 Device Recall SKYLight see related information
Date Posted March 04, 2011
Recall Status1 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 2
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 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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