[Recalled] INFX-8000F Fluoroscopic X-Ray Systems — During an examination a device error occurred and the ceiling drive operation w… | FDA 2017-12-29

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Toshiba American Medical Systems Inc

• INFX-8000C Fluoroscopic X-Ray Systems — Class II
• Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head. — Class II
• TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. — Class II
• Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging — Class II
• INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems — Class II
• Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.