GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Reported: July 30, 2014 Initiated: June 13, 2014 #Z-2085-2014
Product Description
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Reason for Recall
Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 41,992 (20,509 US; 21,483 OUS)
- Distribution
- Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO, MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.. Recalled by GE Healthcare, LLC. Units affected: 41,992 (20,509 US; 21,483 OUS).
Why was this product recalled? ▼
Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2014. Severity: Moderate. Recall number: Z-2085-2014.
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