Device Recall Spacelabs Pediatric Flow Sensor Kit 의 리콜

Recall

70754

Class 2

Z-1458-2015

2015-03-05

2015-04-20

Terminated

United States

2015-11-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134610

Reports of inaccurate low flow readings. monitored inspiratory tidal volume (vti) and expiratory tidal volume (vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actual delivered volumes being administered to the patient.

Spacelabs started mailing the Urgent Medical Device Correction- Pediatric Flow Sensor kit, PN: 376-0561-00 used with Spacelabs 700 and 900 series ventilators letter, dated 17 March 2015, via priority service to all US customers. Spacelabs will be emailing the customer letter (translated as necessary) to all international subsidiaries and distributors of record on March 20, 2015. Customers are asked to dispose of all pediatric flow sensors purchased from Spacelabs (even if they shipped outside of the time frame in which affected product shipped). Customers are requested to complete and return the Business Reply Form to Spacelabs Healthcare either by fax to Global Tech Support at 425-363-5758 or scan the form and email to techsupport@spacelabs.com Spacelabs will send you at no charge replacement pediatric flow sensors (376-0561-01) for all Spacelabs pediatric flow sensors you purchased. These NEW sensors will be marked with a "-01" molded into the body so you can tell the difference between the old sensors and the new ones. For additional information or technical assistance, please contact: Technical Support Spacelabs Healthcare, Inc. 35301 SE Center Street Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support