Toshiba INFX-8000C Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
Toshiba American Medical Systems Inc is recalling 19 INFX-8000C 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 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 is classified as FDA Class II and involves a mechanical defect in a medical device that disabled operation during use, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 19 units of the INFX-8000C Fluoroscopic X-Ray Systems. The recall was initiated after a device error occurred during an examination, which resulted in the ceiling drive operation being disabled.
The investigation determined that the fastening bolts of the driving portion of the ceiling drive had loosened, causing the error. The affected units are distributed in the United States and are identified by specific serial numbers listed in the recall notice.
Healthcare facilities should contact Toshiba American Medical Systems Inc to arrange for inspection and repair of the affected ceiling drive components. The recall is classified as Class II by the FDA.
The recalled product
- Product
- INFX-8000C Fluoroscopic X-Ray Systems
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 19
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 (19)
- Serial Numbers: U6A1472001
- UWB1422001
- U6C13Y2007
- A3A14Z2001
- A6B1532003
- A1B1552001
- A6B1582004
- A9B1622002
- A9A1592001
- A5C1622001
- A6B1682005
- A6B16X2006
- A5C16Y2002
- A1D1752002
- AFA1662001
- A9B1722003
- A6B1742007
- A6A1492002
- A4B1472002
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
- ModerateToshiba INFX-8000H 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
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