Recall Z-0994-2013— Toshiba American Medical Systems Inc
Class II · Terminated
Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2012-11-08, terminated 2013-03-26. It names 4 FDA 510(k) clearances: K120073, K113052, K081624 and 1 more. Product: Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.. Reason: Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed..
- Recalling firm
- Toshiba American Medical Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-08
- Terminated
- 2013-03-26
- Firm location
- Tustin, CA, United States
510(k) clearances named in this recall
4 on FDA's record- K120073 — INFX-8000V WITH
- K113052 — INFINIX-CCI
- K081624 — INFX-8000F (INFINIX CSI AND INFINIX DPI)
- K052884 — MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
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
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
Reason for recall
Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.