Recall Z-1195-06 ยท MJK Dna Probe, Trichomonas Vaginalis
MRL, Inc., A Welch Allyn Company
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
| Date | Jul 8, 2006 (initiated Jun 30, 2006) |
| Status | Terminated |
| Reason | 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. |
| 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 acco |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974034 | PORTABLE INTENSIVE CARE UNIT Medical Research Laboratories, Inc., Mar 2, 1998 |