Recall Z-0524-2019 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Healthcare, LLC
Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
| Date | Aug 31, 2018 |
| Status | Open, Classified |
| Reason | The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time. |
| Root cause | Software design |
| Action | The recalling firm issued letters dated 8/31/2018 via FedEx on 8/31/2018 informing the customer of the issue and providing safety instructions for mitigation of the issue if a prolonged network overload occurs and the Dash and/or Solar patient monitor on the network does not resume normal functionality in approximately 90 seconds. |
| Quantity | Approximately 3,864 monitoring systems |
| Distribution | Distribution was made nationwide, including Puerto Rico, Guam, and Samoa. There was also government and military distribution. Foreign distribution was made to Canada, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosn |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030575 | MODIFICATION TO SOLAR 9500 INFORMATION MONITOR Ge Medical Systems Information Technologies, Mar 21, 2003 |
| K033964 | SOLAR 9500 INFORMATION MONITOR Ge Medical Systems Information Technologies, Jan 15, 2004 |
| K990068 | SOLAR 9500 INFORMATION MONITOR General Electric Medical Systems Information Techn, Jul 14, 1999 |