Recall Z-1617-2016— C.R. Bard, Inc.
Class II · Terminated
Class II FDA medical device recall by C.R. Bard, Inc., initiated 2015-11-09, terminated 2017-06-06. It names one FDA 510(k) clearance: K101092. Product: Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature. Reason: The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup..
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-09
- Terminated
- 2017-06-06
- Firm location
- Covington, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
Reason for recall
The product may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery responsible for maintaining the system close and Static Random Access Memory (SRAM). This premature coin cell battery drainage could render the device unresponsive upon System startup.
Data sourced from openFDA. This site is unofficial and independent of the FDA.