FDA Device

Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00

Hazard

Unit may overestimate Sp02 levels in a high humidity environment.

What You Should Do

Remedy

Dixtal Medical notified accounts by email on 9/27/10 and followed by hard copy Urgent Product Recall letter, dated September 27, 2010. The letter identified the affected product and stated the reason for the recall. The letter also requested that customers to cease distribution and/or use of the suspect product and to return product for replacement. The attached Confirmation Notification should be completed and returned. Customers are to contact Customer Service: sales@dixtal.com, Phone 1-203-269-1112, Fax 1-203-269-1760, with questions or to arrange to have a replacement product provided.

Products

Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00
Brand
Dixtal Medical, Inc.
UPC
Serial Numbers: 139-31479, 139-31485, 139-31465 TO 139-31478,  139-31483 AND 139-31489, 139-31490, 139-31493,  139-31494, 139-31499, 139-31511, 139-31514, 139-31515, 139-31522, 139-31526 & 139-31529, 139-31487, 139-31512 139-31480, 139-31463, 139-31486, 139-31491, 139-31462

Units Affected

35 units