Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.
FDA device recall Z-2111-2020 · posted 2020-05-22 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FMZ
- Quantity affected
- 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.
- Date initiated
- 2020-04-02
- Date posted
- 2020-05-22
- Date terminated
- 2024-05-06
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GIRAFFE OMNIBED (K101788) | Ohmeda Medical | 2010-07-21 |