510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ZOLL Palm Springs

Palm Springs, CA, US

ZOLL Palm Springs appears in FDA device records in Palm Springs, CA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
8
Registered establishments
1

FDA records under these names

2 names

FDA records resolved to ZOLL Palm Springs carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Viasys Respiratory Care, Inc.510(k), recall
  • Viasys Respiratory Care, Inc.dba Bird Productsrecall

510(k) clearance history

FDA records hold 3 510(k) clearances for ZOLL Palm Springs between 2006 and 2011. The busiest year on record is 2006, with 1. The most recent is 2011, with 1.

Clearances by year, as a table
510(k) clearance decisions for ZOLL Palm Springs, by decision year
YearClearances
20061
20081
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K100928MICRO DIARY SPIROMETERBZGSubstantially Equivalent
K073069MODIFICATION TO AVEA VENTILATORCBKSubstantially Equivalent
K062093AVEA VENTILATORCBKSubstantially Equivalent

Registered establishments

FDA registered establishments for ZOLL Palm Springs, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20217102021710ZOLL Palm Springs1100 BIRD CENTER DRIVE, Palm Springs, CA 92262 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0986-2008VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version)Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.Terminated
Z-0985-2008VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version)Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.Terminated
Z-0984-2008VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version)Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.Terminated
Z-0983-2008VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version)Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.Terminated
Z-0982-2008VIASYS 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.Terminated
Z-0638-2007VIASYS 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.Terminated
Z-0481-2007Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.Terminated
Z-0480-2007Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain