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

FDA device recall Z-1214-2012 · posted 2012-03-21 · Terminated

Recall details

Recalling firm

Spectrum Dynamics

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KPS

Quantity affected

Domestic- 35 units, Foreign - 7 units

Distribution

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

Date initiated

2011-07-15

Date posted

2012-03-21

Date terminated

2015-04-01

Location

Caesarea, Israel

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