Toshiba Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Bolt Loosening
Toshiba American Medical Systems is recalling 29 INFX-8000V and INFINIX CF-I/BP PLUS systems because fastening bolts on the ceiling drive loosened, disabling 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical defect in a medical device that disabled operation during use. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 29 units of INFX-8000V Fluoroscopic X-Ray Systems and INFINIX CF-I/BP PLUS CARDIAC SYSTEMS. The recall involves specific serial numbers distributed in the United States.
The recall was initiated after a device error occurred during an examination, which 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.
Healthcare facilities should contact Toshiba American Medical Systems for instructions on how to address the defect. The source text does not specify a remediation method or a deadline for action.
The recalled product
- Product
- INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 29
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 (20)
- Serial Numbers: UFD13X2015
- UFD13X2016
- UUC13Z2011
- UEC1422013
- UFD1442017
- UFD1452018
- AAA1642005
- UUC1452012
- UTC14Y2008
- ACA1472001
- ACA1492002
- AAA1492001
- AAA14X2002
- A8A1532001
- A9A1542001
- AAA1542003
- A9A1582002
- ABB1627001
- ACB1622003
- A9A1662003
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
- ModerateToshiba INFX-8000H Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
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
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Similar recalls
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