InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device
FDA device recall Z-0845-2014 · posted 2014-01-27 · Terminated
Recall details
- Recalling firm
- Philips Healthcare
- Reason for recall
- Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm.
- Action taken
- Philips Healthcare Recall Notice for this proactive performance correction was provided verbally to hospital biomedical engineers. Philips product support engineering scheduled and conducted the update on customer devices to the most current MCB configuration.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NCX
- Quantity affected
- 50
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to: Austria, France, Germany The Netherlands, Spain, Sweden, and Switzerland.
- Date initiated
- 2014-01-13
- Date posted
- 2014-01-27
- Date terminated
- 2014-02-13
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM (K080908) | Innercool Therapies, Inc.- A Delaware Corporation | 2008-10-17 |