Recall Z-1226-2022— GE Healthcare, LLC
Class I · Ongoing
Class I FDA medical device recall by GE Healthcare, LLC, initiated 2022-04-18. It names 2 FDA 510(k) clearances: K142679, K111116. Product: Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116). Reason: Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-04-18
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
2 on FDA's record- K142679 — CARESCAPE R860
- K111116 — ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
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
Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)
Reason for recall
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Data sourced from openFDA. This site is unofficial and independent of the FDA.