Integrity R1 — Class II medical device recall Z-0724-2018
Terminated recall by Elekta Limited, reported 2018-03-07, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Potential for positional errors following automatic table movement (ATM).
| Recall number | Z-0724-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta Limited, Crawley, N/A, United Kingdom |
| Recall initiated | 2017-11-20 |
| Classified | 2018-02-26 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2024-03-15 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, LK, LT, MA, MT, MX, MY, NL, NO, NP, NZ, PA, PE, PH, PK, PL, PT, PY, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, VE, VN, ZA |
| Quantity | 539 units |
Product
Integrity R1.2
Reason for recall
Potential for positional errors following automatic table movement (ATM).
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-0724-2018. 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.