Product Wiki · Recalls · U.S. FDA — Device Enforcement

TX1 Tissue Removal System Console — recall Z-1817-2012

U.S. FDA — Device Enforcement · United States · 2012-02-22 · Class II

As described by U.S. FDA — Device Enforcement: TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user sele

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1817-2012
Date of alert
2012-02-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
American Optisurgical Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide distribution: MN only.
Reported risk: Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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