Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to
FDA device recall Z-1549-2014 · posted 2014-05-06 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
- Action taken
- GE Healthcare notified Biomedical/Clinical Engineering managers, Labor & Delivery/ NICU Nurse managers, Respiratory Therapy Managers and Directors of Risk Management by letter 04/02/2014. End users were advised that they may continue to use the system provided they follow the GE recommended actions: 1) If in use with a patient, turn off the Nellcor SpO2 function in the control panel and switch to an approved alternate form of SpO2 measurement. 2) Prior to using the affected GE warmer with the Nellcor SpO2 function, or resuming the use of this function with any patient, contact your hospital Bio-Med or qualified technician to check the Nellcor SpO2 alarm functionality using either an adult Nellcor SpO2 sensor or a Nellcor SpO2 simulator following the applicable instructions in the Appendix 3) If the test activates a Low Pulse Rate alarm, the user-adjusted Nellcor SpO2 alarm limits are functioning properly and the warmer can be placed back in clinical service. End users were also advised that alarm functionality must be re-checked following every service event requiring access to the internal electronics and during annual preventative maintenance, until revised software is installed. 4) If the test does NOT activate a Low Pulse Rate alarm, remove the warmer from clinical service and contact your local GE Healthcare Service Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- FMT
- Quantity affected
- 21 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2014-04-02
- Date posted
- 2014-05-06
- Date terminated
- 2016-05-11
- Location
- Laurel, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GIRAFFE AND PANDA WARMERS (K123309) | Ohmeda Medical | 2013-02-05 |
| GIRAFFE AND PANDA WARMERS (K122267) | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2012-10-02 |