Recall Z-0521-2019— GE Healthcare, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-08-31. It names 2 FDA 510(k) clearances: K073462, K051367. Product: Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.. 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..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-08-31
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
2 on FDA's record- K073462 — MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
- K051367 — PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.