Recall Z-0494-2013 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that ca
| Date | Dec 16, 2012 (initiated Jun 26, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential issue due to an unexpected loss of Custom Automatic NBP Measurement cycling associated with the Dash 3000/4000/5000 patient monitors. |
| Root cause | Software design |
| Action | GE Healthcare sent a Important Product Information Letter dated June 21, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If your facility is using the Custom Auto NBP Measurement feature in conjunction with Automatic View On Alarm and/or View Other Beds options, GE Healthcare recommends that you stop using the Custom Automatic NBP Measurement feature and use the Auto NBP function instead. All Dash3000/4000/5000 patient monitors with software version 6.0 and later with the networking option enabled may be affe |
| Quantity | 119,260 devices |
| Distribution | Worldwide Distribution -- USA (nationwide) including the countries of AUSTRALIA, ANGOLA,ARGENTINA, AUSTRIA, BAHAMAS, BAHRAIN, BANGLADESH, BELGIUM, BOSNIA HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073462 | MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES Ge Medical Systems Information Technologies, Jan 11, 2008 |