Spectrum Dynamics: 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.

Recall number

Z-1214-2012

Recalling firm

Spectrum Dynamics

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.

Status

Terminated

Initiated

2011-07-15

Posted

2012-03-21

Terminated

2015-04-01

Reason

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

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

Domestic- 35 units, Foreign - 7 units

Distribution

Worldwide Distribution -- USA (nationwide) and the countries of France and United Kingdom

Lot, serial or model codes

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

510(k) numbers

["K072468"]

PMA numbers

not on file

Product code

KPS

Firm FEI

3006451238

Firm city

Caesarea

Firm state

not on file

Firm country

Israel

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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