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U.S. Department of Health and Human Services

Class 2 Device Recall DSPECT"

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 Class 2 Recall
DSPECT"
see related information
Date Posted March 21, 2012
Recall Status1 Open
Recall Number Z-1214-2012
Recall Event ID 61298
Premarket Notification
510(K) Number
K072468 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product D-SPECT" Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System --- SPECTRUM DYNAMICS --- Spectrum Dynamics (Israel) Ltd. 22 Bareket St. North Industrial Park, P.O. Box 3033, Caesarea, 30889 Israel D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV.
Code Information Serial Numbers: 1064, 1065, 1066, 1067, 1068, 1069, 1071, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1084, 1085, 1086, 1088, 1092, 1093, 1094, 1095, 1096, 1097, 1098, 1099, 1101, 1102, 1103, 1105, 1106, 1107, 1061, 1087, 1089, 1090, 1091, 1104
Recalling Firm/
Manufacturer
Spectrum Dynamics
22 Bareket St
Caesarea
Manufacturer Reason
for Recall
The firm received a report related to the detector housing on the D-SPECT Cardiac Scanner. Specifically, it was reported that if the detector housing securing mechanism is compromised, the detector housing may pull away from its secured position on the gantry and potentially come into contact with a patient. The reported event was discovered during set up and thus did not involve a patient or p
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Spectrum Dynamics sent a "Voluntary Field Correction" letter dated July 15, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken. To implement this fix, a BC Technical Field Service Engineer contacted users to schedule a service visit. In the meantime, Spectrum Dynamics did not believe that this issue warranted the discontinuation of use of the D-SPECT Cardiac Scanner. However, in an abundance of caution, if the detector housing appeared to be loose, or appeared to be disconnecting from the gantry, do not use the system. Please contact your local BC Technical Field Service Engineer immediately. Enclosed is a verification form. Please fax the completed form at your earliest convenience to 415.663.4225. For further information or support concerning this issue, please call 925.922.2615.
Quantity in Commerce Domestic- 37 units, Foreign - 7 units
Distribution Worldwide Distribution -- USA (nationwide) and the countries of France and United Kingdom
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 = SPECTRUM DYNAMICS LTD.
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