Mizuho OSI Trios Table Base Recall for Missing Retaining Ring
Mizuho OSI is recalling 33 Trios table bases because a missing retaining ring may cause the clutch to jam, preventing patient rotation.
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 risk-of-harm product (medical device) where a mechanical failure could prevent necessary patient positioning, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Mizuho OSI is recalling 33 units of the Trios Table Base, models 7803 and 7803AP, with serial numbers 228-261. These electronically powered mobile operating table bases are designed for temporary support and positioning of patients in prone, supine, or lateral positions.
The recall is due to a manufacturing defect where the table bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, this missing part can cause the components to go out of alignment, making it difficult to engage or disengage the clutch. If the clutch cannot disengage, the user will be unable to rotate the patient from a supine to a prone position.
The affected units were distributed in the US, South Africa, Japan, and the United Arab Emirates. Users should stop using the affected table bases and contact Mizuho OSI for instructions on how to resolve the issue.
The recalled product
- Product
- Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in…
- Manufacturer
- Mizuho OSI
- Affected units
- 33
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)
- Model numbers 7803
- 7803AP. Serial numbers 228-261.
Distribution
Distribution scope not specified by the agency.
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