FDA Medical Device Recalls (openFDA)
Dixtal Medical, Inc.: Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00
- Recall number
- Z-0550-2011
- Recalling firm
- Dixtal Medical, Inc.
- Product
- Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00
- Status
- Terminated
- Initiated
- 2010-09-27
- Posted
- 2010-12-09
- Terminated
- 2016-08-04
- Reason
- Unit may overestimate Sp02 levels in a high humidity environment.
- 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: sales@dixtal.com, Phone 1-203-269-1112, Fax 1-203-269-1760, with questions or to arrange to have a replacement product provided.
- Quantity
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K032949"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 3006891479
- Firm city
- Wallingford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28