Recall Z-1749-2008 ยท JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Otsuka America Pharmaceutical, Inc.
UBiT-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11.
| Date | Sep 1, 2008 (initiated Jan 18, 2008) |
| Status | Terminated |
| Reason | Medical device power supply may overheat and cause smoke to be emitted from the device. |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | 517 units |
| Distribution | The affected medical devices were distributed to medical facilities and physician offices nationwide and to distributors in Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013371 | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM Otsuka Pharmaceutical Co., Ltd., Dec 21, 2001 |