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Terminated

CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.

FDA Recall Z-0527-04 · Posted 2004-02-10

Recalling FirmGVI Technology Partners
Recall StatusTerminated
Product CodeIYX
Date Initiated2004-01-16
Date Terminated2012-04-12
Product Quantity16 units

Reason for Recall

Due to limitations in the operating software, the acquired scan may not be processed properly.

Firm Action

The firm notified their distributor by letter on 1/16/2004, software upgrade will be installed on each unit.

Root Cause

Other

Distribution Pattern

One Single customer.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023373ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101Gvi Technology Partners · 2003-01-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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