Recall Z-0550-2011 ยท DQA Oximeter
Dixtal Medical, Inc.
Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00
| Date | Dec 9, 2010 (initiated Sep 27, 2010) |
| Status | Terminated |
| 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 provide |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032949 | SPOT CHECK PULSE OXIMETER,512/513 Respironics Novametrix, Inc., Aug 23, 2004 |