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U.S. Department of Health and Human Services

Class 2 Device Recall Tomoscan

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 Class 2 Device Recall Tomoscansee related information
Date Initiated by FirmFebruary 10, 2005
Date PostedApril 06, 2005
Recall Status1 Terminated 3 on May 09, 2008
Recall NumberZ-0682-05
Recall Event ID 31277
Product Classification System, Tomography, Computed, Emission - Product Code KPS
ProductTomoscan
Code Information The firm utilizes site numbers: 6902, 6916, 6975, 6976, 13568, 13616, 13701, 13881, 13945, 14054, 15313, 17178, 17363, 17393, 17438, 17447, 26147, 35424, 35466, 35487, 35499, 37835, 37975, 38026, 38107, 38112, 38264, 38282, 38302, 38347, 38404, 38560, 38596, 38638, 38659, 38721, 38723, 38983, 40234, 40313, 40318, 40387, 41078, 41087, 41194, 41331, 41332, 41338, 41400, 41427, 41428, 41429, 44291, 44710, 44715, 44830, 45021, 45055, 45056, 46641, 50149, 50166, 50304, 50404, 59280, 59287, 59378, 59456, 59537, 59651, 59657, 59705, 62358, 62613, 62654, 62793, 62836, 62860, 62943, 62944, 68203, 73906, 73958, 73990, 74004, 74005, 74020, 76037, 76211, 76361, 76367, 76415, 76416, 76598, 76599, 76929, 82611, 82649, 82830, 82900, 83049, 83055, 84426, 85076, 86024, 86363, 104223, 104301, X0191, X0206, X0224, X0247, X0733, X0927, X1018, X1047, X1058, X1129, X1130, X1133, X1170, X1187, X1213, X1214, X1243, X1245, X1307, X1354, X1368, X1369, X1370, X1432, X1479, X1481, X1482, X1532, X1533, X1672 
FEI Number 1000524572
Recalling Firm/
Manufacturer		 Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Hwy
Bothell WA 98021
For Additional Information ContactSarah Baxter
425-487-7665
Manufacturer Reason
for Recall		Potential for shift of reference lines.
FDA Determined
Cause 2		Other
ActionOn 2/10/05 the firm''s field engineers began visiting customer sites providing them with an addendum to the Instructions for Use Manual.
Quantity in Commerce138
DistributionDevcices were distributed to hospitals and medical centers throughout the U.S.
Total Product Life CycleTPLC 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.
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