Recall Z-2111-2020 ยท FMZ Incubator, Neonatal
GE Healthcare, LLC
Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
| Date | May 22, 2020 (initiated Apr 2, 2020) |
| Status | Terminated |
| Reason | During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor. |
| Root cause | Device Design |
| Action | GE Healthcare notified customers on 04/02/2020 via "Urgent Medical Device Correction" letter. The recall letter identified the affected product and serial numbers. The firm instructed the users to discontinue use of the product if at any time they smell a gas odor. GE Healthcare will correct all affected products at a later date when the correction is available at no cost. |
| Quantity | 204 units. |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, LA, MD, MI, MS, NC, ND, NM, NV, NY, OH, Ok, OR, PA, SC, TN, TX, VA, WA, WI and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101788 | GIRAFFE OMNIBED Ohmeda Medical, Jul 21, 2010 |