Operating Table System — Class II medical device recall Z-1296-2021
Ongoing recall by Getinge Group Logistics America, LLC, reported 2021-03-31, distributed in AK, AL, AR, AZ, CA, CO, DE, FL…. There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Tre
| Recall number | Z-1296-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Group Logistics America, LLC, Wayne, NJ, United States |
| Recall initiated | 2021-02-11 |
| Classified | 2021-03-23 |
| Reported by FDA | 2021-03-31 |
| Distributed | AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KR, KW, LB, LT, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PH, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, TH, TR, TW, VE, VN, ZA |
| Quantity | 4,288 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04046768031500, 04046768031531, 04046768031555, 04046768031579, 04046768040700, 04046768088061, 04046768088351, 04046768124752 |
| Serial numbers | 1028, 1159, 1264, 3402, 401, 762 |
| Model numbers | 118001A0, 118001B0, 118001B1, 118001B2, 118001B3, 118001B4, 118001C0, 118001D0 |
Product
Operating Table System
Reason for recall
There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the 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-1296-2021. 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.