Reported May 14, 2014 · Terminated
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier;…
GE Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare · 8880 Gorman Rd · Laurel, MD · 20723-5800
Is this the product you have?
- 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).
- Lot codes and dates
- 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
BS9SENBS9SESBSAVX8BSAVX9BSAW3ABSAY0PBSAY0UBSAY15BSAY18BSAY1ABSAY1EBSAY1FBSAY1NBSAY1UBSAY1XBSAY3CBSAY3FBSAY3NBSAY3VBSAY3XBSAY5DBSAY5HBSAY8SBSAY9CBSAY9GBSAY9JBSAY9R
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 BSCZRY70 of 70 codes
BSB993BSB9AGBSB9AJBSB9ARBSB9AXBSB9B9BSB9BDBSB9BEBSB9BKBSB9D6BSB9D7BSB9DBBSB9DEBSB9JKBSB9JUBSB9KGBSB9KUBSB9KYBSB9NWBSB9NXBSB9NYBSB9NZBSB9P3BSB9P6BSB9PABSB9PEBSB9PGBSB9PKBSB9PLBSB9PRBSB9PYBSB9R0BSB9R3BSB9R5BSB9R7BSB9R9BSB9RCBSB9RLBSB9RYBSB9RZBSB9S2BSB9S3BSB9S5BSB9SJBSB9SYBSB9SZBSB9T4BSB9T8BSB9TABSB9TDBSB9TGBSB9TJBSB9TMBSB9TSbsb9tuBSB9TXBSB9TZBSB9U1BSB9X6BSB9X7
- Amount recalled
- 301 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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