Z-0550-2011

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

Name: Z-0550-2011 Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00
Creator: Dixtal Medical, Inc.
Published: 2010-09-27
License: https://open.fda.gov/license/

Dixtal Medical, Inc. / initiated 2010-09-27 / Terminated / root cause: manufacturing process

FDA source

Dixtal Medical, Inc. began a recall of Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00 on 2010-09-27. The reason FDA records is "Unit may overestimate Sp02 levels in a high humidity environment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0550-2011
Status: Terminated
Initiated: 2010-09-27
Posted: 2010-12-09
Terminated: 2016-08-04
Recalling firm: Dixtal Medical, Inc.
Product: Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00
Product code: DQA Oximeter
Reason for recall: Unit may overestimate Sp02 levels in a high humidity environment.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: 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: [email protected], Phone 1-203-269-1112, Fax 1-203-269-1760, with questions or to arrange to have a replacement product provided.
Quantity in commerce: 35 units
Distribution: Worldwide Distribution -- USA, including states of AK, KY, NJ, and NY and countries of Australia, Austria, Bolivia, Canada, Finland, Indonesia, Italy, Poland, Sweden, and Switzerland.
Product codes and lots: 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

Product code DQA

K032949Class IISpot Check Pulse Oximeter,512/513Respironics Novametrix, Inc. / cleared 2004-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)