Toshiba INFX-8000H Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
Toshiba is recalling two INFX-8000H Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a mechanical failure (loosened bolts) that disabled the device, which fits the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported or is theoretical.
Plain-English summary
Toshiba American Medical Systems Inc is recalling two units of the INFX-8000H Fluoroscopic X-Ray System. The recall involves specific serial numbers A5B1672001 and AFA1692002, which were distributed in the United States.
The recall was initiated after a device error occurred during an examination that disabled the ceiling drive operation. An investigation found that the fastening bolts of the driving portion of the ceiling drive had loosened, causing the error.
The source text does not specify instructions for consumers or healthcare providers on how to proceed, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- INFX-8000H Fluoroscopic X-Ray Systems
- Manufacturer
- Toshiba American Medical Systems Inc
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Numbers: A5B1672001
- AFA1692002
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Toshiba American Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Toshiba American Medical Systems Inc
See all →- ModerateToshiba Diagnostic Ultrasound Systems Recalled for Power Supply Defect
FDA (Devices) · 2018-07-04
- HighToshiba INFX-8000C Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
FDA (Devices) · 2018-03-14
- HighToshiba Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Bolt Loosening
FDA (Devices) · 2018-03-14
- HighToshiba INFX-8000F Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
FDA (Devices) · 2018-03-14
- ModerateToshiba Medical Kalare Fluoroscopic X-Ray System Recalled for Image Display Failure
FDA (Devices) · 2017-10-25
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateAlphenix INFX-8000H systems recalled over ceiling suspension screws that loosen
FDA (Devices) · 2026-02-04
- SevereToshiba Infinix X-Ray System Recalled for Table Movement Safety Issue
FDA (Devices) · 2014-06-11
- ModerateToshiba INFX-8000V X-Ray System Recalled for Dose Meter Error
FDA (Devices) · 2016-02-17
- HighCanon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
FDA (Devices) · 2026-09-02
- ModerateAlphenix INFX-8000F systems recalled over ceiling suspension screws that loosen
FDA (Devices) · 2026-02-04
- ModerateAlphenix INFX-8000C systems recalled over ceiling suspension screws that loosen
FDA (Devices) · 2026-02-04