Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module The CUSA NXT Ultrasonic Surgical Aspirator System is i

FDA device recall Z-2585-2011 · posted 2011-06-17 · Terminated

Recall details

Recalling firm

Integra Limited

Reason for recall

The insulated covering of a wire cable that powers the vacuum pump in the CUSA NXT Service Module can become abraded over time resulting in the exposure of bare wire. If this bare wire were to come in contact with the metal surface of the pump, it could result in a short circuit and a loss of aspiration.

Action taken

Integra sent a "FIELD ACTION NOTIFICATION" dated May 2, 2011 to all affected customers. The letter identified the product, the problem and the actions to be taken. Customers were informed of a Field Corrective Action that is being initiated. All devices (customer owned, Integra Loaner Pool, and Sales demos) will undergo rework of the vacuum pump assembly. The rework will be scheduled, at customer sites by Integra Field Service Technicians or returned to a designated Integra Service Center for rework. A loaner will be presented to customer accounts upon request. The letter asks that each customer complete and return the enclosed Recall Acknowledgement and Return Form to Integra, maintaining a copy of the letter and form for your records. For any additional information please call 609-936-2485.

Root cause

Device Design

Status

Terminated

Product code

LFL

Quantity affected

105 units

Distribution

Worldwide -- USA (nationwide) and countries of France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, Sweden and Taiwan

Date initiated

2011-05-02

Date posted

2011-06-17

Date terminated

2014-03-26

Location

Plainsboro, NJ

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