Manufacturer Recalls: GE Incubator/Carestation Latches

GE Healthcare URGENT Medical Device Recall for Incubators and Omnibeds.

 

Issue

GE Healthcare announced a recall on October 11th, 2019 on their Giraffe Incubators, Giraffe Omnibeds, and Giraffe Incubator Carestations bedside panels and portholes that may appear closed without being latched, causing a potential patient to fall.

Recalled Products

The following GE Healthcare NICU products are affected by this recall:

  • All Giraffe Incubators and Giraffe Omnibeds
  • Giraffe incubator Carestation (2082844-002-xxx) [GTIN – 010084068211685521]
  • Giraffe Omnibed Carestation (2082844-001-xxx) [GTIN – 010084068211686221]
  • Devices Recalled in the U.S.: unknown.
  • Date Initiated by Firm: October 11th, 2019
  • Attached is GE Healthcare’s PDF with additional details on this recall for the Incubator/Carestation latch issue: FMI32070 Customer Letter IncubatorOmnibed

US Med-Equip’s Solution

Any GE Incubator/Carestation units from US Med-Equip (USME) are currently being inspected and labeled for any faulty latches so as to prevent any adverse accidents. The units that are currently being rented and coming off of rent are also being inspected and labeled for any damages pertaining to this recall. In addition, GE Healthcare will provide a user manual addendum, labels for the device, and instructional poster materials in a future mailing at no cost to you. If you have an affected GE Incubator/Carestation from USME, please email qa@usmedequip.com to place your report.

GE Healthcare Contact Information

If you have any questions or concerns regarding this notification, please contact GE Healthcare Services at

Phone: 1-800-437-1171

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s

MedWatch Adverse Event Reporting program online; complete and submit the report online here.

The US Med-Equip Mission

Our Mission is to promote the healing process by providing smart solutions for our partners and the patients they serve.

We are committed to your patients as much as you are — it’s rooted in our daily actions — so we understand the importance of safely servicing recalls promptly.

For any further questions regarding equipment recalls, please reach out to qa@usmedequip.com.