UBiT-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11.
FDA Recall Z-1749-2008 · Posted 2008-09-01
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Recalling FirmOtsuka America Pharmaceutical, Inc.
Recall StatusTerminated
Product CodeJJQ
Date Initiated2008-01-18
Date Terminated2011-02-18
Product Quantity517 units
Reason for Recall
Medical device power supply may overheat and cause smoke to be emitted from the device.
Firm Action
The initial distributor in the US notified consignees 03/14/08 and 03/26/08 by letter. Consignees were provided two different letters depending on the hours of use of the spectrophotometer. The notifications advised of the firm's preventive service and upgrade program for the instrument's power supply, in which consignees would receive a temporary replacement instrument while the service is completed. Consignees with spectrophotometers having <15000 light source hours were notified similarly, and were provided filters and instructions for cleaning and replacing the filters to protect the power supply from unnecessary accumulation of debris. Contact firm at 1-888-MERETEK for assistance.
Root Cause
Nonconforming Material/Component
Distribution Pattern
The affected medical devices were distributed to medical facilities and physician offices nationwide and to distributors in Mexico.
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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