Reported Oct 17, 2018 · Ongoing
GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]:…
GE Healthcare Finland Oy
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 Finland Oy · Kuortaneenkatu 2 · Helsinki · N/A
Is this the product you have?
- GE Healthcare
- CARESCAPE Monitor B450 Product UsageIntended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor
- B450 is indicated for monitoring of-hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation, -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), and spirometry) -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission)
- Lot codes and dates
- Serial numbersNo
- UDI
2,172 of 2,172 codes
SJA15150092HASJA15150100HASJA15150124HASJA15150125HASJA15150126HASJA15150127HASJA15150128HASJA15150139HASJA15170033HASJA15170079HASJA15170081HASJA15170085HASJA15170086HASJA15170087HASJA15170088HASJA15170089HASJA15170090HASJA15170091HASNE16060190HASNE16110218HASJA14127613HASJA14127614HASJA15262026HASJA15262173HASJA15272036HASJA15282008HASJA15282009HASJA15282010HASJA15282014HASJA15282015HASJA15282016HASJA15282017HASJA15282019HASJA15282022HASJA15282024HASJA15282043HASJA15282044HASJA15282048HASJA15282051HASJA15282054HASJA15282055HASJA15282059HASJA15282060HASJA15282063HASJA15282065HASJA15282118HASJA15282122HASJA15282125HASJA15282128HASJA15282129HASJA15282131HASJA15282134HASJA15282135HASJA15282141HASJA15282149HASJA15382048HASJA14437335HASJA14437337HASJA14127619HASJA14127621HA
- Amount recalled
- 59,000 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new GE Healthcare Finland Oy recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.