Recall Z-0752-2016— Toshiba American Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2015-08-14, terminated 2016-05-18. It names 4 FDA 510(k) clearances: K152696, K143225, K133535 and 1 more. 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"..
- Recalling firm
- Toshiba American Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-14
- Terminated
- 2016-05-18
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
4 on FDA's record- K152696 — INFX-8000V, V6.20
- K143225 — INFX-8000V with Wireless Footswitch
- K133535 — INFX-8000V, V5.30
- K120073 — INFX-8000V WITH
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Reason for recall
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".
Data sourced from openFDA. This site is unofficial and independent of the FDA.