Medical Laboratory Instruments Recalled Due to Electrical Short Circuit Fire Risk
Ventana Medical Systems has recalled 9,214 BenchMark ULTRA and DISCOVERY ULTRA instruments due to potential fluid leak that could cause electrical short circuit, smoke, and fire.
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: FDA Class II medical device recall. The hazard presents a risk of serious harm (smoke and fire from electrical short circuit), but no injuries or deaths have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Ventana Medical Systems Inc. has recalled BenchMark ULTRA and DISCOVERY ULTRA instruments. These are medical laboratory instruments used in staining systems. The recall applies to units with serial numbers 322030 or lower.
A potential fluid leak inside the staining system could cause an electrical short circuit in the General Purpose Input/Output Board's J1 Connector. This malfunction could result in smoke and fire.
The recalled instruments have been distributed throughout the United States and internationally, including to Canada, United Kingdom, France, Germany, Japan, China, and numerous other countries.
The recalled product
- Product
- BenchMark ULTRA and DISCOVERY ULTRA Instruments
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 9,214
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 (1)
- Serial Numbers Less-Than-Or-Equal-To 322030
Distribution
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