FDA (Devices) recall action 86646
The FDA (Devices) publishes a recall like this one as 17 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 17 pages.
Ventilator may experience potential issues with the backup battery failures: 1) if the battery is allowed to over discharge, or 2) if the ventilator is stored for an extended period of time without being plugged into AC power.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Respironics is recalling 934 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power.
Respironics is recalling 3,453 V680 Ventilators because the backup battery may fail if over-discharged or stored without AC power.
Respironics is recalling 835 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.
Respironics is recalling 9,863 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.
Respironics is recalling 481 V60 Ventilators due to potential backup battery failures caused by over-discharge or extended storage without AC power.
Respironics is recalling 10,441 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.
Respironics is recalling 2,144 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.
Respironics is recalling 3,887 V60 Plus Ventilators because the backup battery may fail if over-discharged or stored without AC power.
Respironics is recalling 3,213 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power.
Respironics is recalling 46,313 V60 Ventilators worldwide due to a risk of backup battery failure if over-discharged or stored without AC power.
Respironics is recalling 534 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.
Respironics is recalling 292 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power.
Respironics is recalling three V60 Ventilators due to potential backup battery failures caused by over-discharge or extended storage without AC power.
Respironics is recalling 702 V60 Plus Ventilators worldwide because the backup battery may fail if over-discharged or stored without AC power.
Respironics is recalling 330 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.
Respironics is recalling 3,752 V60 Ventilators worldwide due to a risk of backup battery failure if over-discharged or stored without AC power.
Respironics is recalling 216 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.