FDA Medical Device Recalls (openFDA)
GVI Technology Partners: CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.
- Recall number
- Z-0527-04
- 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.
- Status
- Terminated
- Initiated
- 2004-01-16
- Posted
- 2004-02-10
- Terminated
- 2012-04-12
- Reason
- Due to limitations in the operating software, the acquired scan may not be processed properly.
- Root cause
- Other
- Action
- The firm notified their distributor by letter on 1/16/2004, software upgrade will be installed on each unit.
- Quantity
- 16 units
- Distribution
- One Single customer.
- Lot, serial or model codes
- S/Ns: 100 thur 105, and 107 thru 116.
- 510(k) numbers
- ["K023373"]
- PMA numbers
- not on file
- Product code
- IYX
- Firm FEI
- 3003917438
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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