Z-1505-2017Class II

Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators...

Name: Z-1505-2017 Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators...
Creator: Ohmeda Medical
Published: 2016-11-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2016-11-18 / Terminated / root cause: manufacturing process

FDA source

Ohmeda Medical began a recall of Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who... on 2016-11-18. FDA classified it as Class II and gives the reason as "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...". 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-1505-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-18
Posted: 2017-03-20
Terminated: 2018-07-13
Recalling firm: GE Healthcare
Product: 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. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Product code: FMZ Incubator, Neonatal
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: According to the firm, this issue will be resolved by sending an Urgent Medical Device Correction customer letter to customers with affected Power Cords. This letter will inform the customer of the issue and provide safety instructions for immediate mitigation of the issue. The long-term solution is to re-place all affected Power Cords at no cost to the customer. According to the firm, the plan for public notification is to contact all customers with affected Power Cords by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to the following titles within the affected accounts; Nurse Managers, Labor & Delivery/NICU, Bio-Medical Engineering Department Managers and Risk Management Directors We will track all service requests for the field action to completion. These service requests will record the replacement of the affected Power Cords. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures.
Quantity in commerce: 5,993 (5,080 US; 913 OUS)
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, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,
Product codes and lots: See Attached Spreadsheat

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1505-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1501-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1502-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1503-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1504-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1505-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1506-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1507-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1508-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1509-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1510-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20
Z-1511-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20

Product code FMZ

K020547Class IIOhmeda Medical Giraffe IncubatorOhmeda Medical / cleared 2002-05-09

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)