Z-0527-04

CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version...

Name: Z-0527-04 CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version...
Creator: GVI Technology Partners
Published: 2004-01-16
License: https://open.fda.gov/license/

Gvi Technology Partners / initiated 2004-01-16 / Terminated / root cause: software

FDA source

GVI Technology Partners began a recall of CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech on 2004-01-16. The reason FDA records is "Due to limitations in the operating software, the acquired scan may not be processed properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0527-04
Status: Terminated
Initiated: 2004-01-16
Posted: 2004-02-10
Terminated: 2012-04-12
Recalling firm: Gvi Technology Partners
Product: CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.
Product code: IYX Camera, Scintillation (Gamma)
Reason for recall: Due to limitations in the operating software, the acquired scan may not be processed properly.
Root cause tag: software
FDA root cause: Other
Action: The firm notified their distributor by letter on 1/16/2004, software upgrade will be installed on each unit.
Quantity in commerce: 16 units
Distribution: One Single customer.
Product codes and lots: S/Ns: 100 thur 105, and 107 thru 116.

Product code IYX

K023373Class IOnepass Nuclear Imaging System, Model 70-500101Gvi Technology Partners / cleared 2003-01-03

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)