Mizuho Operating Table Hand Control Units Recalled for Sliding Risk
Mizuho OSI is recalling 26 operating table hand control units because they may cause the tabletop to slide in the opposite direction, potentially delaying surgical procedures.
What this means for you
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 used during surgery where a malfunction could delay a procedure, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mizuho OSI is recalling 26 units of the Mizuho CE IPX4 operating table hand control unit (model MOT-5602BW). These devices are intended to support patients during surgical operations. The recall covers units distributed in California and in the countries of Costa Rica, Chile, Bolivia, and Peru.
The recall was initiated because there is a potential that the hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This malfunction could result in a delay in the surgical procedure. The source text does not report any injuries or illnesses associated with this defect.
Affected units are identified by specific serial numbers for the control unit and operating table, which are listed in the official recall documentation. Healthcare facilities should stop using these units and contact Mizuho OSI for further instructions on the recall.
The recalled product
- Product
- Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
- Manufacturer
- Mizuho OSI
- Category
- Medical Device — Operating Table
- Affected units
- 26
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 (20)
- S/N (Control unit) - S/N (Operating table): 10290134 - MEC-20195-0034
- 10290135 - MEC-20195-0036
- 10290136 - MEC-20195-0035
- 10290137 - MEC-20195-0033
- 10490143 - MEC-20198-0038
- 10490144 - MEC-20198-0037
- 10490145 - MEC-20198-0040
- 10490147 - MEC-20198-0039
- 10690148 - MEC-2019Y-0054
- 10690149 - MEC-20199-0049
- 10690150 - MEC-2019Y-0059
- 10690153 - MEC-2019Y-0058
- 10690154 - MEC-20199-0046
- 10690155 - MEC-2019Y-0057
- 10690156 - MEC-20199-0050
- 10690157 - MEC-20199-0044
- 10690159 - MEC-20199-0047
- 10690160 - MEC-20199-0051
- 10690161 - MEC-20199-0045
- 10690162 - MEC-20199-0048
Distribution
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