Recall Z-0747-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
| Date | Jan 14, 2014 (initiated Nov 27, 2013) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012. |
| Root cause | Device Design |
| Action | The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 26, 2013 to its consignees/customers. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The consignees/customers were instructed to please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE Healthcare will provide a new latch at no |
| Quantity | 43,033 (25,681 USA; 17,352 OUS) |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN, MS, NO, NE, NV, NJ, NM, NY, NC, OH, OK,OR, PA, RI, SC, TN, TX, UT,VT, VA, WA, WI, and WY. Internationally to: Argentina, Australia, Austria, Bangladesh, Bel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071073 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE Ge Medical Systems Information Technologies, May 11, 2007 |