Infant Warmer System (IWS) 의 리콜

Recall

75210

Class 2

Z-1015-2017

2016-08-04

Terminated

United States

2018-07-12

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149672

Ge healthcare has recently become aware of a potential safety issue related to loose screws in the heater head of the infant warmer system (iws). hot screws from the heater head of the iws could fall onto the bed if the heater head assembly has been improperly serviced. this situation can be clinically hazardous because thermal injury to a patient could result. two injuries have been reported as a result of this issue.

This recall strategy includes the depth of the recall, plan for public warning and effectiveness check. The strategy outlined below addresses these elements for this particular recall. The plan for public warning is to contact all customers with potentially affected product by means of an Urgent Medical Device Correction letter. The letter will instruct customers that they can continue to use the device by following instructions on the Addendum to the Service Manual. The Service Manual Addendum provides instructions for checking and tightening the screws. In the US the letter will be sent by a traceable means [either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX]. This letter will be sent to: Nurse Manager, Labor & Delivery/NICU; Manager, Bio-Medical Engineering; and Director of Risk Management.