GE Healthcare — Class II medical device recall Z-1562-2016
Terminated recall by GE Medical Systems, LLC, reported 2016-05-04, distributed in AZ, CA, DC, FL, GA, ID, IL, IN…. The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm require
| Recall number | Z-1562-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2016-03-15 |
| Classified | 2016-04-22 |
| Reported by FDA | 2016-05-04 |
| Terminated | 2016-11-07 |
| Distributed | AZ, CA, DC, FL, GA, ID, IL, IN, KY, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AE, AU, BE, BO, CA, CH, CL, DE, DK, ES, FI, FR, GB, IE, IN, JP, KR, KW, NL, NZ, SA, TH, TR |
| UPC / GTIN / UDI-DI | 00097911150511, 00137511150624, 00184711150831, 00191211150902, 00193811150917, 00199311150921, 00203911150929, 00211811151007, 00212511151014, 00213211151014, 00215611151014, 00216311151014, 00217011151014, 00225711151029, 00226411151029, 00227211151103, 00234011151103, 00235511151112 |
Product
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).
Reason for recall
The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient.
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-1562-2016. 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.