Device recall: Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical…
Class II FDA enforcement event 76283. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Ohmeda Medical started this device recall on 18 Nov 2016. The firm address in the FDA record is in Laurel, MD. FDA put the recall in Class II. FDA event 76283 has 11 product records. The first FDA enforcement report date is 29 Mar 2017. The record gives the status Terminated, with the termination date 13 Jul 2018.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras,…
Recalling firm
Ohmeda Medical, Laurel, MD.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1501-2017 | Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the Giraffe OmniBed, incubators and warmers… | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
| Z-1502-2017 | Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed temperature controlled environment | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
| Z-1503-2017 | Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
| Z-1504-2017 | Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and… | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
| Z-1505-2017 | Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant.… | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
| Z-1506-2017 | Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to… | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
| Z-1507-2017 | 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… | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
| Z-1508-2017 | Giraffe Bedded Warmer, Panda Warmer Modifiction to Giraffe and Panda Warmer- 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… | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
| Z-1509-2017 | Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed,… | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
| Z-1510-2017 | CarePlus Incubator Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. Most Incubators… | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
| Z-1511-2017 | IWS Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal… | 5,993 (5,080 US; 913 OUS) | Class II | Terminated | 29 Mar 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 11Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Oct 2018 | Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device ca | Device | Class II | 1 |
| 1 Dec 2017 | Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that m | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1501-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 76283. https://recallregister.com/fda/ii/76283/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras,…
- What quantity of product is in FDA event 76283?
- The event has 11 product records. The first record gives this quantity:
5,993 (5,080 US; 913 OUS)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.