Recall Z-1801-2010 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Ge Healthcare, Llc
GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE " Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicat
| Date | Jun 11, 2010 (initiated May 6, 2010) |
| Status | Terminated |
| Reason | GE Healthcare has become aware of a safety issue associated with the CARESCAPE" Monitor B850 when monitoring ECG. The safety issue includes the potential for a delay in treatment. |
| Root cause | Software design |
| Action | The customers were sent on May 6, 2010, a GE Healthcare "Urgent Medical Device Correction" letter dated April 22, 2010. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, Director of Biomedical Engineering. The letter listed the Safety Issue, Affected Product Details, Product Correction, Safety Instructions and Contact Information. The customers were instructed to immediately discontinue use of the "Update Lead Set" function until the device software has been upgraded. If you have any questions regarding this medical device correction or identification o |
| Quantity | 798 units. (229 USA, 569 OUS) |
| Distribution | Worldwide distribution: USA including CO, MA, NC, WI, and countries of UNITED KINGDOM, SWITZERLAND, SWEDEN, SPAIN, SINGAPORE, PORTUGAL, NORWAY NETHERLANDS, ITALY, INDIA, GERMANY, FRANCE, FINLAND, BELGIUM, and AUSTRALIA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.