FDA Device recall Z-2064-2016
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19 by Carefusion 303, citing A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alar….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2064-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-12 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Reason
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
Identifiers
| code_info | Serial no. 14566816 14566942 14566976 14567039 14567041 14567050 14567060 14567079 14567084 14567085 1456712…Serial no. 14566816 14566942 14566976 14567039 14567041 14567050 14567060 14567079 14567084 14567085 14567126 14567131 14567132 14567144 14412839 14509419 14509442 14509601 14510079 14510087 14517114 14517126 14517135 14517137 14517139 14517179 14517183 14517186 14517193 14517202 14517205 14517208 14517214 14517218 14517220 14517246 14517250 14517253 14517254 14517256 14517257 14517259 14517260 14517282 14517286 14517287 14517296 14517297 14517301 14517303 14517305 14517309 14517310 14517312 14517314 14517315 14517316 14517318 14517319 14517323 14517324 14517326 14517327 14517336 14517337 14517339 14517341 14517345 14517346 14517351 14517356 14517359 14517360 14517362 14517363 14517364 14517369 14517372 14517373 14517378 14517381 14517383 14517388 14517389 14517391 14517393 14517396 14517400 14517401 14517402 14517403 14517409 14517415 14517417 14517418 14517421 14517424 14517428 14517430 |
|---|
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-2064-2016%22
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