FDA Device recall Z-0752-2016
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
- FDA Device
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems by Toshiba American Medical Systems, citing when a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the so….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0752-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-14 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
Product
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Reason
When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".
Identifiers
| code_info | Serial Numbers ACA1492002, AAA1492001, W4B1442020, and W4B1432018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0752-2016%22
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