CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report
Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe recalled
Ohmeda Medical is recalling Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe, distributed nationwide in the US. The recall was initiated on 18 Nov 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1507-2017
- FDA event ID
- 76283
- Recalling firm
- Ohmeda Medical, Laurel, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Nov 2016
- FDA classified
- 20 Mar 2017
- Reported
- 29 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 18 Nov 2016 | Recall initiated by company | |
| 20 Mar 2017 | Classified by FDA | +122 days |
| 29 Mar 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide 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.
Where it was distributed
Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,
Questions about this recall
Why was it recalled?
Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
Which lots are affected?
See Attached Spreadsheat
Where was it sold?
Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 76283This product is part of a recall event; the main page for the event is Giraffe Bedded Warmer, Panda Warmer Giraffe recalled by Ohmeda Medical.
More recalls from Ohmeda Medical
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Giraffe Omnibed recalled by Ohmeda Medical | Ohmeda Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Rotating IV Pole Rotating IV Pole falls under the category recalled | Ohmeda Medical | Other | Nationwide |
| Device | CLASS II | Giraffe Exam Light The Exam Light illuminates body surfaces recalled | Ohmeda Medical | Other | Nationwide |
| Device | CLASS II | Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed recalled | Ohmeda Medical | Temperature Abuse | Nationwide |
| Device | CLASS II | IWS Infant Warmer System-Infant radiant warmers provide recalled | Ohmeda Medical | Temperature Abuse | Nationwide |
Other Patient Monitors recalls
All 1,013| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |