Puritan Bennett 980 Series Ventilator
Check against the official notice below — it lists the full affected range.
Medtronic has recalled approximately 18,412 Puritan Bennett 980 Series Ventilators distributed in the United States due to a defect where the audible alarm may not sound and the omni-directional LED visual alarm may not display during alarm states. This means that users may not be alerted when the ventilator experiences an alarm condition. The potential failure to receive timely alarm notification could delay a patient's treatment response and result in serious medical complications including hypoxia, difficulty breathing, cardiac arrest, or death.
The recall affects ventilators with specific lot and serial numbers listed in the recall notice. The record does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.
Reason for recall: The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death. Distribution: US Nationwide - Worldwide .Distribution Quantity: 18,508 OUS; 18,412 US Lot/code info: Lot/Serial Number | Product GTIN/MATNR 35B2014306 10884521171633 35B2014309 10884521171633 35B2014312 10884521171633 35B2014314 10884521171633 35B1500319 10884521201408 35B1500321 10884521201521 35B1500322 10884521201408 35B1500323 10884521201408 35B1500324 10884521201408 35B1500718 10884521201408 35B1500744 10884521201408 35B1500758 10884521201408 35B1500773 10884521201408 35B1502000 10884521212251 35B1502094 10884521201354 35B1502099 10884521201354 35B1502104 10884521201354 35B1502172 10884521201224 35B1600140 10884521201224 35B1600170 10884521201224 35B1600182 10884521201224 35B1600188 10884521201224 35B1600198 10884521201224 35B1600202 10884521201224 35B1600203 10884521201224 35B1600204 10884521201224 35B1600209 10884521201224 35B1600211 10884521201224 35B1600213 10884521212251 35B1600216 10884521201224 35B1600217 10884521201897 35B1600218 10884521201910 35B1600221 10884521201224 35B1600225 10884521201224 35B1600228 10884521201224 35B1600242 10884521201224 35B1600251 10884521201224 35B1600274 10884521201224 35B1701370 10884521201408 35B1701377 10884521201408 35B1701395 10884521201408 35B1701429 10884521201408 35B1701445 10884521201408 35B1701451 10884521201408 35B1701495 10884521201408 35B1702271 10884521201521 35B1702336 10884521201521 35B1703244 10884521201521 35B1703347 10884521201521 35B1703348 10884521201521 35B1703354 10884521201521 35B1800087 10884521201408 35B1800112 10884521201408 35B1800114 10884521201408 35B1800129 10884521201408 35B1800130 10884521201408 35B18
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.