CLASS II ONGOING Device recall · Reported 3 Mar 2021 · FDA Enforcement Report
Philips Battery, V60 14.4V, 11.0 Ah, 163 Wh recalled
Respironics California is recalling Philips Battery, V60 14.4V, 11.0 Ah, 163 Wh, distributed nationwide in the US. The recall was initiated on 6 Jan 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1137-2021
- FDA event ID
- 87314
- Recalling firm
- Respironics California, Carlsbad, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Jan 2021
- FDA classified
- 19 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 6 Jan 2021 | Recall initiated by company | |
| 19 Feb 2021 | Classified by FDA | +44 days |
| 3 Mar 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to unqualified "design verification" batteries being shipped to customers.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
Where it was distributed
U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.
Nationwide FloridaGeorgiaIowaIllinoisMinnesotaMissouriNorth CarolinaNorth DakotaOhioTexasUtah
Questions about this recall
Why was it recalled?
Due to unqualified "design verification" batteries being shipped to customers.
Which lots are affected?
Battery Model/Part Number: 1076374 Lot Code: M94663-P1
Where was it sold?
U.S. Nationwide distribution including in the states of FL, GA, IA, IA, IL. IL, MN, MO, NC, ND, OH, TX, TX and UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Respironics California
All 45| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Philips Respironics V60 Ventilator (All recalled | Respironics California | Other | Nationwide |
| Device | CLASS I | Philips Respironics V60 Plus Ventilator (All recalled | Respironics California | Other | Nationwide |
| Device | CLASS I | Philips Respironics V680 Ventilator (All recalled | Respironics California | Other | Nationwide |
| Device | CLASS I | Philips Respironics V60 Ventilator recalled by Respironics California | Respironics California | Device Malfunction | 13 states |
| Device | CLASS I | Philips Respironics V60 Plus Ventilator recalled | Respironics California | Device Malfunction | 13 states |
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| Device | CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
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| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |