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American Optisurgical Recalls
4 recalls on record · June 27, 2012 to June 19, 2013 · Medical Devices
Recalls by year
12
13
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 19, 2013Medical DevicesFDA
American Optisurgical Inc recalls TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use i
Hazard: American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.
June 12, 2013Medical DevicesFDA
American Optisurgical Inc recalls American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in s
Hazard: The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop wo
June 12, 2013Medical DevicesFDA
American Optisurgical Inc recalls FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Hazard: American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.
June 27, 2012Medical DevicesFDA
American Optisurgical Inc recalls TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and
Hazard: 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.