Z-0915-2014Class II

Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE...

Name: Z-0915-2014 Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE...
Creator: GE Healthcare
Published: 2013-12-12
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-12-12 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare began a recall of Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD... on 2013-12-12. FDA classified it as Class II and gives the reason as "Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0915-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-12
Posted: 2014-02-03
Terminated: 2015-06-01
Recalling firm: GE Healthcare
Product: Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: GE Healthcare notified end users with a letter flagged as Urgent Medical Device Correction letter on 12/12/2013. The notification advised that GE Healthcare has become aware of a potential safety issue associated with the loosening of the blender knob shaft on all Resuscitation units. The firm advised that accounts ensure that all potential users in their facility are made aware of this safety notification and the recommended actions described in the notification: 1. Perform blender accuracy check as outlined in Section 2.5-2.5.1 of the Service Manual to verify that the O2 concentration set at 21% is within 16-26% O2 and the concentration at 100% setting is within the recommended range (95-105% O2). 2. If the blender accuracy test results do not meet specifications, remove the unit from patient use and contact a GE Healthcare Service Representative at the number listed below. 3. If the blender accuracy check passes in Step 1 above, you may continue to use your resuscitation system. The following precautions are recommended to ensure blender accuracy is maintained between system checks. Use an independent oxygen analyzer, as determined by your hospital policy, to check blended Air/O2 accuracy. When delivering Oxygen, use a pulse oximeter to monitor your patient. Customers were requested to contact a GE Healthcare Service Representative at 1-800-345-2700 to arrange for correction if the device is found to be defective.
Quantity in commerce: 48 units
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Uruguay, Venezuela, Albania, Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Canada, Chile, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: Serial Numbers: 402055 402149 402151 402155 402168 402172 402134 401758 401759 401760 401761 401762 401767 401769 401772 401775 401776 401825 401773 401777 401771 401774 401778 401766 401763 401764 401765 401768 401770 400802 400657 400434 400768 401203 401208 402081 402245 402180 401965 400493 400504 400506 401998 402345 402352 400311 401481 410773

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0915-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0912-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03
Z-0913-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03
Z-0914-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03
Z-0915-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03
Z-0916-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03
Z-0917-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

Product code BTM

K070247Class IIGiraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical / cleared 2007-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)