Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported March 5, 2014
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: 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. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These ar
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Ge Healthcare, LLC recalled GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant… — a critical-severity action.
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant… was recalled by Ge Healthcare, LLC in March 5, 2014. Reason: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assemb…. Check the official notice for the remedy. Verify recall #Z-1070-2014 with the FDA Devices before acting.
The recall
Ge Healthcare, LLC issued this critical-severity FDA Devices recall — Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assemb….
- Critical
- severity level
- Class I
- classification
- March 5, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1070-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1070-2014) was formally reported on March 5, 2014, with the manufacturer initiating the action on October 1, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Ge Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records list the affected scope as 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown.
The documented reason for this recall is: Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown
Related Recalls
6
6 from same agency
Product description
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: 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. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
Reason for recall
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1070-2014 |
| Date reported | March 5, 2014 |
| Date initiated | October 1, 2013 |
| Recalling firm | Ge Healthcare, LLC |
| Firm location | Waukesha, WI |
| Affected scope | 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown |
| Distribution | Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1070-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: 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. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.. Recalled by Ge Healthcare, LLC. Units affected: 12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown.
Why was this product recalled? ▼
Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 5, 2014. Severity: Critical. Recall number: Z-1070-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Albania, Austria, Australia, Bahrain, Belarus, Belgium, Canada, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, Germany, Honduras, Hong Kong, Hungry, India, Indonesia, Ireland, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Saudi Arabia, South Africia, Spain, Sweden, Switzerland Turkey, United Arab, United Kingdom, and Venezuela..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1070-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 5, 2014.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.