Puritan Bennett 980 — Class I medical device recall Z-0497-2019
Terminated recall by COVIDIEN LLC, reported 2018-12-26, distributed nationwide. Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality a
| Recall number | Z-0497-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN LLC, Mansfield, MA, United States |
| Recall initiated | 2018-09-18 |
| Classified | 2018-12-18 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2021-02-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BG, CA, CH, CL, CZ, DE, ES, FR, GB, GR, HK, HR, HU, IE, IL, IR, IT, JP, KE, KW, LB, LT, LV, NL, OM, PK, PL, PT, RO, SA, SE, SI, SK, TN, TR, TW, UY, ZA |
| Quantity | 9,593 |
| Reason classes | labeling, software |
| Serial numbers | 35B1300001 |
Product
Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively, to patients who require the followingtypes of ventilator support: Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask or nasal prongs). Assist/ Control, SIMV or Spontaneous modes of ventilation
Reason for recall
Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
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-0497-2019. 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.