Z-1181-2018Class II

Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional...

Name: Z-1181-2018 Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional...
Creator: Ohmeda Medical
Published: 2017-12-01
License: https://open.fda.gov/license/

GE Healthcare / initiated 2017-12-01 / Terminated / root cause: design

FDA source

Ohmeda Medical began a recall of Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate... on 2017-12-01. FDA classified it as Class II and gives the reason as "There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1181-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-01
Posted: 2018-03-26
Terminated: 2019-09-17
Recalling firm: GE Healthcare
Product: Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.
Product code: FOX Stand, Infusion
Reason for recall: There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.
Root cause tag: design
FDA root cause: Device Design
Action: On December 1, 2017 an URGENT MEDICAL DEVICE CORRECTION letter was issued to customers notifying of the recall. The letter requested customers to discontinue use of the affected Rotating IV poles and remove from Service. Place affected Rotating IV poles in a quarantine marked area. A GE Service Representative will contact you to arrange for the removal & replacement of a new IV pole. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. For further questions, please call (410) 888-5376.
Quantity in commerce: 1,179 (1,004 US; 175 OUS)
Distribution: USA (nationwide)
Product codes and lots: Model Number(s): 6600-0851-800 Affected lot codes are within LAU13921134 - LAU14720444

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1181-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1181-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code FOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)