Puritan Bennett 840 ventilator systems software part number… — Class I medical device recall Z-0611-2014
Terminated recall by Covidien, reported 2014-01-15, distributed nationwide. Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with cert
| Recall number | Z-0611-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, Boulder, CO, United States |
| Recall initiated | 2013-12-16 |
| Classified | 2014-01-03 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2016-11-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CH, CL, CN, CR, CY, CZ, DE, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MX, MY, NL, NZ, PA, PE, PL, PT, RO, RS, RU, SA, SG, SI, TN, TR, TW, UY, ZA |
| Reason classes | software |
| Model numbers | 4-070212-85 |
Product
Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
Reason for recall
Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0611-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.