Recall Z-0748-2013— GE Healthcare, LLC
Class I · Terminated
Class I FDA medical device recall by GE Healthcare, LLC, initiated 2012-10-15, terminated 2017-01-18. It names one FDA 510(k) clearance: K070210. Product: GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.. Reason: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-10-15
- Terminated
- 2017-01-18
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
Reason for recall
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.