UBiT-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11.
FDA device recall Z-1749-2008 · posted 2008-09-01 · Terminated
Recall details
- Recalling firm
- Otsuka America Pharmaceutical, Inc.
- Reason for recall
- Medical device power supply may overheat and cause smoke to be emitted from the device.
- Action taken
- 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
- Status
- Terminated
- Product code
- JJQ
- Quantity affected
- 517 units
- Distribution
- The affected medical devices were distributed to medical facilities and physician offices nationwide and to distributors in Mexico.
- Date initiated
- 2008-01-18
- Date posted
- 2008-09-01
- Date terminated
- 2011-02-18
- Location
- Rockville, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (K013371) | Otsuka Pharmaceutical Co., Ltd. | 2001-12-21 |