Data / Medical devices / United States / ZOLL Palm Springs
ZOLL Palm Springs: FDA-registered device maker in Palm Springs, CA, United States, 1 PMA approval
ZOLL Palm Springs is registered with the FDA (registration 2021710) in Palm Springs, CA, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated March 29, 1991. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2021710
- Address
- 1100 Bird Center Drive, Palm Springs, CA, United States, 92262
- Owner or operator
- ZOLL Medical Corporation (1220908)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- November 13, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer for export | accessdata.fda.gov |
| Ventilator, High Frequency | LSZ | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 29, 1991 | P890057 | MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR | LSZ | 22 | July 23, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 17, 2007 | 46215 | Not yet classified | Terminated | VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version) | Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition. | accessdata.fda.gov |
| January 31, 2007 | 37318 | Not yet classified | Terminated | VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc. | The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms. | accessdata.fda.gov |
| October 20, 2006 | 36740 | Not yet classified | Terminated | Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653 | The reason for this correction is due to the potential of a repeat ''failure to cycle'' event. | accessdata.fda.gov |
Compare with other makers
Updated July 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.