FDA Device recall Z-1192-2023
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255 by Carefusion 303, citing infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to tr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1192-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-24 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carefusion 303 |
| Distribution | 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255
Reason
Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed
Identifiers
| code_info | All PC Units, UDI-DI: 10885403801549, 10885403801532, with software versions 12.1.0, 12.1.2, 12.1.3, utilizing affected network cards and IP addresses |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1192-2023%22
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