Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00
FDA Recall Z-0550-2011 · Posted 2010-12-09
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Recalling FirmDixtal Medical, Inc.
Recall StatusTerminated
Product CodeDQA
Date Initiated2010-09-27
Date Terminated2016-08-04
Product Quantity35 units
Reason for Recall
Unit may overestimate Sp02 levels in a high humidity environment.
Firm 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.
Root Cause
Equipment maintenance
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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