Laser and endoscopy systems recalled over ferrites omitted from a USB cable
Beaver-Visitec International is recalling 5 BVI Leos Laser and Endoscopy Systems because ferrites specified for the USB cable assembly were not installed as intended.
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: Scored 2 because the record cites a design specification non-conformance with no stated consequence or reported harm.
Plain-English summary
The BVI Leos Laser and Endoscopy System, model OME6000U, is being recalled by Beaver-Visitec International, Inc.
The record cites a manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites, one at each end of the cable.
The record lists 5 units carrying UDI (01)00886158037576, with serial numbers listed in the enforcement record including 77UBV500003 and 77UBV500004. Distribution was nationwide in the United States, in Florida, Michigan, Oklahoma, Texas and Wisconsin. The FDA has classified the action as Class II.
The record describes a non-conformance to the design specification and states no further consequence or reported injuries. Facilities should follow the firm's instructions.
The recalled product
- Product
- BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
- Manufacturer
- Beaver-Visitec International, Inc.
- Affected units
- 5
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 (4)
- 77UBV500004
- 77UBV500005
- 77UBV500006
- 77UBV500010.
Distribution
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