Welch Allyn Protocol, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 16
At a glance
Market reach
- United States
- FDA recalls
What Welch Allyn Protocol, Inc. makes
Welch Allyn Protocol, Inc. manufactures vital signs monitoring devices, including standalone monitors like the VSM 300 and 53000 series, as well as integrated systems such as the ProPaq Encore and ProPaq CS models. Their portfolio also includes modifications to central monitoring systems like the Acuity Central Monitoring System and clinician notification tools like the Acuity Clinician Notifier. Additional offerings include the ProPaq LT vital signs monitor and the MicroPaq series for portable monitoring.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. Welch Allyn Protocol, Inc. is based in the United States.
Catalogue
Modification To Acuity Central Monitoring System Ref K022453
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Vsm - Vital Signs Monitor, Model 53000 Series Ref K031740
Regimes: 510(k) Registry: 510(k)Micropaq, Models 402, 404 Ref K021681
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Link To Acuity Clinician Notifier Ref K070204
Regimes: 510(k) Registry: 510(k)Vital Signs Monitor, Propaq Lt Ref K033378
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 16 recalls initiated by Welch Allyn Protocol, Inc., the earliest on 2003-12-31 and the most recent on 2013-11-21. By recorded status: 16 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware and electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 21 Nov 2013 Z-0633-2014 Class II Terminated Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.
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- 21 Nov 2013 Z-0633-2014 Class II Terminated Welch Allyn will update Propaq 802 Series Vital Signs Monitor, models are 802LTAN, 802LTON and 802LTR with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.
2011
- 16 May 2011 Z-2918-2011 Unclassified (pre-2012) Terminated Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.
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- 16 May 2011 Z-2918-2011 Unclassified (pre-2012) Terminated Aruba Wireless Network Access Points, Model Number 65, experienced a higher than expected incidence of dropouts due to external RF interference.
2010
- 17 Sep 2010 Z-0937-2011 Unclassified (pre-2012) Terminated Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The loss of the ability to view the patient's Electrocardiogram (ECG) on the screen could cause the user to delay or fail to administer defibrillating shocks needed to resuscitate a patient.
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- 17 Sep 2010 Z-0937-2011 Unclassified (pre-2012) Terminated Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The loss of the ability to view the patient's Electrocardiogram (ECG) on the screen could cause the user to delay or fail to administer defibrillating shocks needed to resuscitate a patient.
2009
- 28 Jul 2009 Z-1873-2009 Unclassified (pre-2012) Terminated The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms.
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- 1 May 2009 Z-0349-2011 Unclassified (pre-2012) Terminated The 19" Model VG930M ViewSonic flat panel LCD display may have faulty capacitors at certain locations in the power supply section. The faulty capacitors may cause a loss of power to the display resulting in the display screen going dark and loss of both visual and secondary patient alarms.
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- 24 Apr 2009 Z-1656-2009 Unclassified (pre-2012) Terminated Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to
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- 26 Feb 2009 Z-1389-2009 Unclassified (pre-2012) Terminated Issue #1: AED 10 displayed a "Do Not Use" symbol as a result of a blown F1 fuse. Issue #2: AED 10 models that incorporate a spring connector with the speaker experienced intermittent electrical connection to the circuit board causing a loss of voice prompts.
- 28 Jul 2009 Z-1873-2009 Unclassified (pre-2012) Terminated The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms.
2008
- 15 Dec 2008 Z-1005-2009 Unclassified (pre-2012) Terminated Potential for device to shut down prematurely under certain circumstances.
- 15 Dec 2008 Z-1006-2009 Unclassified (pre-2012) Terminated Reliability issues - potential to shock a non shockable rhythm or not shocking a shockable rhythm;
- 15 Dec 2008 Z-1007-2009 Unclassified (pre-2012) Terminated Potential for device to deliver less than the programmed energy.
Show all 16 recalls
2007
- 26 Oct 2007 Z-0129-2008 Unclassified (pre-2012) Terminated Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient
- 23 Aug 2007 Z-1223-2007 Unclassified (pre-2012) Terminated Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
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2006
- 22 Oct 2006 Z-0215-2007 Unclassified (pre-2012) Terminated Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.
- 22 Oct 2006 Z-0216-2007 Unclassified (pre-2012) Terminated Potential to burn patient's finger. A Nellcor pulse oximetry (Sp02) sensor became hot when used with a Propaq LT.
2004
- 8 Jun 2004 Z-1333-04 Unclassified (pre-2012) Terminated Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.
2003
- 31 Dec 2003 Z-0538-04 Unclassified (pre-2012) Terminated Potential failure to audibly alarm due to speaker hardware component failure.
Frequently asked questions
How many devices does Welch Allyn Protocol, Inc. have in the registry?
The registry currently lists 7 devices for Welch Allyn Protocol, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Welch Allyn Protocol, Inc.'s devices?
Among its 7 most recently registered devices, Welch Allyn Protocol, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Welch Allyn Protocol, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Welch Allyn Protocol, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Welch Allyn Protocol, Inc.?
FDA recall records list 16 recalls initiated by Welch Allyn Protocol, Inc., the most recent initiated on 21 Nov 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Welch Allyn Protocol, Inc. in the registry?
The most recently registered devices listed for Welch Allyn Protocol, Inc. include MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM, MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ), VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES and MICROPAQ, MODELS 402, 404.