GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece… — Class I medical device recall Z-0606-2013
Terminated recall by GE Healthcare, LLC, reported 2013-01-02, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pre
| Recall number | Z-0606-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2012-06-26 |
| Classified | 2012-12-26 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2014-04-14 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AT, AU, BD, BE, BH, CA, CH, CN, CZ, DE, EG, ES, FI, FR, GB, GR, ID, IE, IL, IN, IT, JO, KR, MY, NL, NO, NZ, PL, PT, RO, RU, SA, SE, SG, SK, TH, TR, ZA |
| Quantity | 209,804 circuits |
| Lot numbers | 1981713 |
Product
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.
Reason for recall
Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0606-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.