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Terminated

Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001 GTIN: 00840682110808.

FDA Recall Z-2111-2020 · Posted 2020-05-22

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeFMZ
Date Initiated2020-04-02
Date Terminated2024-05-06
Product Quantity204 units.

Reason for Recall

During Giraffe Shuttle charging, the batteries emit low concentrations of gases (outgassing) producing a strong sulfur odor.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101788GIRAFFE OMNIBEDOhmeda Medical · 2010-07-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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