Welch Allyn Protocol, Inc
Medical device manufacturer in Beaverton, OR.
7510(k) clearances
0PMA approvals
14recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K070204 | Link to Acuity Clinician NotifierMSX · Special | 03/23/2007SE |
| K063419 | Modification to Vsm- Vital Signs Monitor, (VSM 300 )MWI · Special | 12/04/2006SE |
| K033378 | Vital Signs Monitor, Propaq LTMWI · Traditional | 03/01/2004SE |
| K031740 | VSM - Vital Signs Monitor, Model 53000 SeriesDQA · Traditional | 08/26/2003SE |
| K022453 | Modification to Acuity Central Monitoring SystemDSI · Special | 08/21/2002SE |
| K021681 | Micropaq, Models 402, 404DRT · Special | 07/23/2002SE |
| K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246DRT · Special | 08/20/2001SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0633-2014 Class II | The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These…Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with… | 11/21/2013Terminated |
| Z-2918-2011 | Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring…Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of… | 05/16/2011Terminated |
| Z-0937-2011 | Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use…Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The… | 09/17/2010Terminated |
| Z-1873-2009 | Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor…The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio… | 07/28/2009Terminated |
| Z-0349-2011 | ViewSonic 19" flat panel LCD display Model VG930M which is used as part of the Welch…The 19" Model VG930M ViewSonic flat panel LCD display may have faulty capacitors at certain locations in the… | 05/01/2009Terminated |
| Z-1656-2009 | Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED…Possible for users to misunderstand signals. The original product labeling told users that a flashing low… | 04/24/2009Terminated |
| Z-1389-2009 | Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED…Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models… | 02/26/2009Terminated |
| Z-1007-2009 | Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED…Potential for device to deliver less than the programmed energy. | 12/15/2008Terminated |
| Z-1006-2009 | Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED…Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm; | 12/15/2008Terminated |
| Z-1005-2009 | Welch Allyn AED 10 Automated External DefibrillatorPotential for device to shut down prematurely under certain circumstances. | 12/15/2008Terminated |
| Z-0129-2008 | Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery…Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating… | 10/26/2007Terminated |
| Z-1223-2007 | Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery…Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on… | 08/23/2007Terminated |
| Z-0216-2007 | Propaq LT vital signs monitor, Model 802LTRNPotential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a… | 10/22/2006Terminated |
| Z-0215-2007 | Propaq LT vital signs monitor, Model 802LTONPotential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a… | 10/22/2006Terminated |