Events

Recall of Nellcor SpO2 Upgrade kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68067
  • Event Risk Class
    Class 2
  • Event Number
    Z-1551-2014
  • Event Initiated Date
    2014-04-02
  • Event Date Posted
    2014-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126903
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Warmer, infant radiant - Product Code FMT
  • Reason
    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
    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.

Device

Nellcor SpO2 Upgrade kit
  • Model / Serial
    BS9SEN BS9SES BSAVX8 BSAVX9 BSAW3A BSAY0P BSAY0U BSAY15 BSAY18 BSAY1A BSAY1E BSAY1F BSAY1N BSAY1U BSAY1X BSAY3C BSAY3F BSAY3N BSAY3V BSAY3X BSAY5D BSAY5H BSAY8S BSAY9C BSAY9G BSAY9J BSAY9R BSAYAR BSAYAU BSAYB1 BSAYBW BSAYBX BSAYC3 BSAYC9 BSAYCB BSAYCC BSAYCD BSAYGV BSAYGX BSAYGY BSAYGZ BSAYH0 BSAYH4 BSAYH6 BSAYIG BSAYJC BSAYJD BSAYOW BSAYOZ BSAYPM BSAYPU BSAYR5 BSAYSA BSAYSJ BSB993 BSB9AG BSB9AJ BSB9AR BSB9AX BSB9B9 BSB9BD BSB9BE BSB9BK BSB9D6 BSB9D7 BSB9DB BSB9DE BSB9JK BSB9JU BSB9KG BSB9KU BSB9KY BSB9NW BSB9NX BSB9NY BSB9NZ BSB9P3 BSB9P6 BSB9PA BSB9PE BSB9PG BSB9PK BSB9PL BSB9PR BSB9PY BSB9R0 BSB9R3 BSB9R5 BSB9R7 BSB9R9 BSB9RC BSB9RL BSB9RY BSB9RZ BSB9S2 BSB9S3 BSB9S5 BSB9SJ BSB9SY BSB9SZ BSB9T4 BSB9T8 BSB9TA BSB9TD BSB9TG BSB9TJ BSB9TM BSB9TS bsb9tu BSB9TX BSB9TZ BSB9U1 BSB9X6 BSB9X7 BSB9X8 BSB9X9 BSB9XA BSB9XF BSB9XG BSB9XR BSB9XX BSB9Y6 BSB9Y7 BSB9YB BSBCUJ BSBCUS BSBCV1 BSBCV2 BSBCVB BSBCWP BSBOTA BSBOTE BSBOU2 BSBOU8 BSBPTL BSBXTL BSBXTT BSBXTX BSBXU1 BSBXUO BSCE5J BSCEC4 BSCEC5 BSCEC6 BSCEE5 BSCEEC BSCEED BSCEEF BSCEEH BSCEEJ BSCEEW BSCEHH BSCEHN BSCEHR BSCEHW BSCEHX BSCEHZ BSCEKP BSCEKT BSCEKV BSCM9V BSCMA8 BSCMA9 BSCMAD BSCZPT BSCZPU BSCZPW BSCZPY BSCZR6 BSCZR7 BSCZR9 BSCZRC BSCZRO BSCZRP BSCZRW BSD0B1 BSDOAK BSDOAT BSDOAU BSDOAY BSDOAZ BSEJGJ BSA41K BSAY0K BSAY21 BSAYA0 BSAYBC BSAYBH BSAYBN BSB9PX BSB9RR BSB9SB BSB9TH BSB9SA BSB9AV BSBCV5 BSCZRJ BSCZRY
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. || 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).
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 8880 Gorman Rd, Laurel MD 20723-5800
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA