Z-1195-06

Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V...

Name: Z-1195-06 Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V...
Creator: MRL, Inc., A Welch Allyn Company
Published: 2006-06-30
License: https://open.fda.gov/license/

MRL, Inc., A Welch Allyn Company / initiated 2006-06-30 / Terminated

FDA source

MRL, Inc., A Welch Allyn Company began a recall of Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured... on 2006-06-30. The reason FDA records is "The Welch Allyn PIC 50 Defibrillators may display a 'Defib Comm' or 'Pace Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1195-06
Status: Terminated
Initiated: 2006-06-30
Posted: 2006-07-08
Terminated: 2007-11-20
Recalling firm: MRL, Inc., A Welch Allyn Company
Product: Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089
Product code: MJK Dna Probe, Trichomonas Vaginalis
Reason for recall: The Welch Allyn PIC 50 Defibrillators may display a 'Defib Comm' or 'Pace Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
FDA root cause: Other
Action: MRL sent Urgent Medical Device Recall letters dated 6/30/06 via certified mail to the direct accounts informing them of an intermittent connection between a pin and socket on a circuit board inside of the device that could result in a malfunction that prevents or unacceptably delays the delivery of a defibrillating shock, which possibly could result in failure to resuscitate the patient. The accounts were provided a list of the affected units' parts/serial numbers and requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. The accounts were also instructed to respond to the notification within 5 working days if the unit has displayed the Defib Comm error, and within 30 days if it has not displayed the Defib Comm error by fax or mail. A loaner PIC 50 will then be sent to the consignee with instructions on how to return their unit for correction.
Quantity in commerce: 673 units - USA, 511 units - International
Distribution: Worldwide-including USA, Puerto Rico, Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sultanate of Oman, Switzerland, United Arab Emirates, United Kingdom and Vietnam.
Product codes and lots: Part numbers 971081, 971082, 971083 and 971084; serial numbers 80104, 80119, 80120, 80204, 80211, 80212, 80429, 80432, 80569, 80627, 80661, 80685, 80880, 80964, 81056, 81134, 81263, 81293/81295, 81303, 81445/ 81448, 81733, 81738, 81739, 81744/81752, 81757, 81761/81781, 81802/81807, 81824, 81825, 81835, 81845, 81846, 81852, 81864, 81865, 81868, 81869, 81884/81886, 81892/81897, 81918/81955, 81957, 81983/81990, 81996/82025, 82027/82033, 82035/82039, 82043, 82044, 82061/82080, 82084, 82097/82111, 82122/82128, 82133, 82136/82143, 82150/82169, 82172/82204, 82245, 82252/82273, 82283/82286, 82307/82330, 82340/82349, 82405/82426, 82430, 82460/82490, 82498/82553, 82555/82565, 82568/82570, 82612/82631, 82654/82673, 82689, 82690, 82773/82813, 82827/82830, 82852, 82856/82859, 82906, 82936, 82937, 82958/82977, 82983/83013, 83060/83071, 83083/83090, 83093, 83142/83147, 83153/83172, 83198/83239, 83255, 83368/83370, 83400/83407, 83414/83418, 83420/83429, 83440/83443, 83499/83517, 83578/83580, 83633, 83644, 83645, 83654, 85001/85005, 85009/85013, 85026/85029, 85032/85052, 85073/85079, 85093, 85094, 85110, 85111, 85143/85157, 85187/85201, 85223, 85224, 85226/85238, 85244/85249, 85329, 85332/85334, 85337/85350, 85364, 85365, 85368/85370, 85381, 85388/85398, 85402/85404, 85410/85414, 85420/85433, 85441, 85505/85515, 85517/85520, 85522/85530, 85534, 85552, 85554/85557, 85587/85589, 85602/85607, 85619/85623, 85630, 85645/85655, 85658/85667, 85686, 85728/85734, 85755/85757, 85761/85766, 85771/85785, 85787/85793, 85810, 85812/85823, 85825/85838, 85856/85872, 85877/85884, 85888/85902, 85931/85933, 85945, 85955, 85964, 85967/85970, 86017, 86018, 86024/86029, 86055/86057, 86103, 86104, 86118, 86141/86147, 86149, 86150, 86222/86228, 86230, 86245, 86256/86258, 86261/86268, 86281/86283, 86289/86293, 86295, 86296, 86299, 86305, 86306, 86314, 86315, 86320/86322, 86324/86328, 86334, 86335, 86358, 86359, 86385, 86387, 86389/86399, 86400, 86411, 86412, 86419, 86420, 86439, 86440

Product code MJK

K974034Class IIPortable Intensive Care UnitMedical Research Laboratories, Inc. / cleared 1998-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)