FDA Device recall Z-0724-2018
Integrity R1.2
- FDA Device
- Class II
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class II recall of Integrity R1.2 by Elekta, citing potential for positional errors following automatic table movement (ATM).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0724-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-20 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elekta |
| Distribution | 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 |
Product
Integrity R1.2
Reason
Potential for positional errors following automatic table movement (ATM).
Identifiers
| code_info | Product code 90I--YE, no serial number |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0724-2018%22
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