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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-1551-2011
Recall Event ID 57589
510(K)Number K000908 
Product Classification Emission Computed Tomography System - 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 CA 95134-1702
408-468-3000
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 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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