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Giraffe Infant Warmers integrated with Nellcor SpO2 recallZ-1547-2014 · GE Healthcare · initiated Apr 2, 2014

Class II Terminated All recalls posted in May 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1547-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 2, 2014
Posted by the FDA
May 6, 2014
Recalling firm
GE Healthcare
Quantity
50 units
Product code
FMT
FDA submissions
K122267, K123309
Distribution
Worldwide Distribution.

Product description

Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).

Code information (models, lots, serial numbers)

HDJM50062 HDJM50093 HDJM50470 HDJM50654 HDJM51812 HDJS55099 HDJS53396 HDJS53397 HDJS53398 HDJT50393 HDJS55036 HDJS55037 HDJS55038 HDJT50318 HDJS52165 HDJS52166 HDJS52119 HDJS52120 HDJR57563 HDJR57564 HDJR57565 HDJR57566 HDJR57567 HDJR57568 HDJR57569 HDJS50733 HDJS52092 HDJS52093 HDJS51002 HDJS51003 HDJS51004 HDJS51005 HDJS51006 HDJP50601 HDJP50606 HDJN50376 HDJS50790 HDJS50791 HDJS50792 HDJS50159 HDJS50160 HDJS51426 HDJS51427 HDJS50734 HDJS50735 HDJS52118 HDJT50534 HDJT50039 HDJR58198 HDJS50316

Other devices under the same FDA submission

3 devices cleared under K122267, K123309 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 68067).

Sources and updates

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