Z-1214-2012

D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System --- SPECTRUM...

Name: Z-1214-2012 D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System --- SPECTRUM...
Creator: Spectrum Dynamics
Published: 2011-07-15
License: https://open.fda.gov/license/

Spectrum Dynamics, Ltd. / initiated 2011-07-15 / Terminated / root cause: manufacturing process

FDA source

Spectrum Dynamics began a recall of D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System --- SPECTRUM DYNAMICS --- Spectrum Dynamics (Israel) Ltd. 22 Bareket... on 2011-07-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1214-2012
Status: Terminated
Initiated: 2011-07-15
Posted: 2012-03-21
Terminated: 2015-04-01
Recalling firm: Spectrum Dynamics, Ltd.
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.
Product code: KPS System, Tomography, Computed, Emission
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
Root cause tag: manufacturing process
FDA root cause: 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- 35 units, Foreign - 7 units
Distribution: Worldwide Distribution -- USA (nationwide) and the countries of France and United Kingdom
Product codes and lots: 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

Product code KPS

K072468Class IIModification to D-Spect Cardiac Scanner SystemSpectrum Dynamics , Ltd. / cleared 2007-10-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)