CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, markete
FDA device recall Z-0527-04 · posted 2004-02-10 · Terminated
Recall details
- Recalling firm
- GVI Technology Partners
- Reason for recall
- Due to limitations in the operating software, the acquired scan may not be processed properly.
- Action taken
- The firm notified their distributor by letter on 1/16/2004, software upgrade will be installed on each unit.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYX
- Quantity affected
- 16 units
- Distribution
- One Single customer.
- Date initiated
- 2004-01-16
- Date posted
- 2004-02-10
- Date terminated
- 2012-04-12
- Location
- Twinsburg, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONEPASS NUCLEAR IMAGING SYSTEM, MODEL 70-500101 (K023373) | Gvi Technology Partners | 2003-01-03 |