Mizuho Microsurgical Operating Room Tables Recalled for Unintended Tilting
Mizuho America is recalling eight microsurgical operating room tables due to unintended tilting and infrared signal errors.
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 medical device with a functional defect (unintended tilting and signal errors) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mizuho America, Inc. is recalling eight units of the Microsurgical Operating Room Tables, model 7300B (18-350-70). The recall involves specific units identified by codes MUC-20168-0001 through MUC-20178-0008.
The recall was initiated because of unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors affecting Tabletops MST 7300B and MST 7300BX.
The affected units were distributed in the United States to Arizona, California, Florida, Missouri, North Carolina, Ohio, Pennsylvania, Texas, and Wisconsin, as well as in Greece, Israel, Japan, and Ukraine. The source text does not specify instructions for consumers or healthcare facilities regarding the next steps for these devices.
The recalled product
- Product
- Microsurgical Operating Room Tables;7300B (18-350-70);
- Manufacturer
- Mizuho America, Inc.
- Affected units
- 8
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 (7)
- MUC-20168-0001
- MUC-20168-0002
- MUC-20171-0003
- MUC-20171-0004
- MUC-20173-0005
- MUC-20173-0006
- MUC-20178-0007 & MUC-20178-0008
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mizuho America, 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 2 products in this recall →Related recalls
Same manufacturer · Mizuho America, Inc.
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