Servo-s Ventilator Systems; Article number 66 40 440. Intended for treatment and monitoring of patients in the range of

FDA device recall Z-2629-2011 · posted 2011-06-23 · Terminated

Recall details

Recalling firm

Maquet Inc.

Reason for recall

Through customer complaints, Maquet has been informed that SERVO-i ventilators have stopped to ventilate and have generated three different technical error codes.

Action taken

Maquet Inc. sent an URGENT DEVICE SAFETY ALERT letter dated April 20, 2011, to all affected customers via Federal Express. The letter identified the product, the problem and the action needed to be taken by the customer. The letter informs the user of the issue and provides additional instruction and how the existing manual should be updated. Customers are asked to fill out the attached response form and fax it to 1-973-807-9210. The following warning will be included in all user's manuals delivered with new ventilators: 'Warning ! The Servo-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction. Warning! The Servo-s Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.' Additionally the warning stated above will be included in the format of a sticker with the yearly preventive maintenance kit for Servo-i and SErvo-s to update exiting User's manuals for the installed base of Servo-i and SErvo-s ventilators. A maintenance report form will also be included in the kit which serves as an acknowledgement from the user that the sticker has been added to an affected ventilator unit's operating manual. For further questions, please call (973) 709-7660.

Root cause

Other

Status

Terminated

Product code

CBK

Quantity affected

17039 units worldwide; 842 units US

Distribution

Worldwide Distribution - USA (nationwide)

Date initiated

2011-04-20

Date posted

2011-06-23

Date terminated

2013-09-17

Location

Wayne, NJ