Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 11, 2015
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients wh
Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalled Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The… - a moderate-severity action.
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The… was recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.) in February 11, 2015. Reason: Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI tr…. Check the official notice for the remedy. Verify recall #Z-1058-2015 with the FDA Devices before acting.
The recall
Covidien LP (formerly Nellcor Puritan Bennett Inc.) issued this moderate-severity FDA Devices recall-Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI tr….
- Moderate
- severity level
- 418 units
- affected scope
- Class II
- classification
- February 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1058-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1058-2015) was formally reported on February 11, 2015, with the manufacturer initiating the action on January 12, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Covidien LP (formerly Nellcor Puritan Bennett Inc.) is listed as the recalling firm, operating out of Boulder, CO. Federal records list the affected scope as 418 units.
The documented reason for this recall is: Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
418 units
Related Recalls
6
3 from same agency
Product description
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who require the following types 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
Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1058-2015 |
| Date reported | February 11, 2015 |
| Date initiated | January 12, 2015 |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.) |
| Firm location | Boulder, CO |
| Affected scope | 418 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1058-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator support, delivered invasively or noninvasively, to patients who require the following types 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.. Recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.). Units affected: 418 units.
Why was this product recalled? ▼
Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2015. Severity: Moderate. Recall number: Z-1058-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1058-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 11, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.