RecallRadar

FDA Device recall Z-0031-2019

Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751

On 2018-10-10 the FDA classified a Class II recall of Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751 by Oridion Medical 1987, citing the date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0031-2019
ClassificationClass II
Statusterminated
Initiated2018-07-31
Published2018-10-10
Last updated2026-09-13 11:54 UTC
CompanyOridion Medical 1987
DistributionUS

Product

Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751

Reason

The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.

Identifiers

code_info
B500002176 B500002177 B500002186 B500002191 B500002192 B500002194 B500002199 B500002201 B500002202 B500002204…B500002176 B500002177 B500002186 B500002191 B500002192 B500002194 B500002199 B500002201 B500002202 B500002204 B500002205 B500002206 B500002207 B500002208 B500002209 B500002210 B500002211 B500002212 B500002213 B500002214 B500002215 B500002216 B500002217 B500002218 B500002219 B500002220 B500002224 B500002225 B500002228 B500002229 B500002233 B500002236 B500002239 B500002240 B500002241 B500002245 B500002249 B500002250 B500002251 B500002252 B500002256 B500002258 B500002259 B500002261 B500002262 B500002265 B500002269 B500002270 B500002271 B500002272 B500002273 B500002274 B500002276 B500002277 B500002278 B500002279 B500002280 B500002281 B500002282 B500002283 B500002284 B500002285 B500002286 B500002287 B500002288 B500002291 B500002292 B500002293 B500002294 B500002295 B500002297 B500002298 B500002300 B500002301 B500002170 B500002234 B500002260 B500002266 B500002267 B500002296 B500002350 B500002351 B500002352 B500

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-0031-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.