Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00
FDA device recall Z-0550-2011 · posted 2010-12-09 · Terminated
Recall details
- Recalling firm
- Dixtal Medical, Inc.
- Reason for recall
- Unit may overestimate Sp02 levels in a high humidity environment.
- Action taken
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 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.
- Date initiated
- 2010-09-27
- Date posted
- 2010-12-09
- Date terminated
- 2016-08-04
- Location
- Wallingford, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPOT CHECK PULSE OXIMETER,512/513 (K032949) | Respironics Novametrix, Inc. | 2004-08-23 |