RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to mo
FDA device recall Z-2597-2014 · posted 2014-09-06 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Action taken
- Radiometer sent an Product Notification letter dated July 31, 2014 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. The letter informed customers that local RADIOMETER IT specialist will contact customers in order to schedule the upgrade to v. 2.74 or 3.5.2. All RADIANCE versions below 2.7X will be upgraded to v. 2.74 or 3.5.2. For questions regarding this letter or the Recall, please contact Radiometer America Technical Support at 1-800-736-0600 opt.4.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- N/A
- Distribution
- Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of: Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.
- Date initiated
- 2014-07-28
- Date posted
- 2014-09-06
- Date terminated
- 2014-10-15
- Location
- Westlake, OH
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