Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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.

FDA Recall Z-1293-2021 · Posted None

Recalling FirmMizuho OSI
Recall StatusOpen, Classified
Product CodeGDC
Date Initiated2021-02-08
Product Quantity26 units

Reason for Recall

There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This could result in a delay in procedure.

Firm Action

On 2/3/2021 Mizuho sent a "Recall Notice for Control Unit" notification letter to affected consignees via Email. In addition to informing consignees about the recall the notification asked consignees to take the following actions: 1. Identify if you have the affected product, 2. Mizuho will replace control units. As soon as we are ready for your institutions, Mizuho will supply the replacements. Please use the auxiliary switch on the operating table until the replacements arrive.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the state of CA, and the countries of Costa Rica, Chile, Bolivia, Peru.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑