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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 Tomoscan see related information
Date Initiated by Firm February 10, 2005
Date Posted April 06, 2005
Recall Status1 Terminated 3 on May 09, 2008
Recall Number Z-0682-05
Recall Event ID 31277
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Tomoscan
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 
Recalling Firm/
Manufacturer		 Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Hwy
Bothell WA 98021
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall		 Potential for shift of reference lines.
FDA Determined
Cause 2		 Other
Action On 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 Commerce 138
Distribution Devcices were distributed to hospitals and medical centers throughout the U.S.
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.
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