Recall Z-0343-2007 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 WelchAllyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089-Part Numbers-971081,971082,971083,971084.
| Date | Jan 19, 2007 (initiated Nov 15, 2006) |
| Status | Terminated |
| Reason | Shock Delay:The monitor-defibrillator may display an 'ECG Comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. This delay could result in failure to resuscitate the patient. |
| Root cause | Other |
| Action | MRL sent Urgent Medical Device Recall letters dated 11/8/06 via certified mail on 11/15/06 to the direct accounts informing them of an intermittent connection between the J5 cable and its mating connector on a circuit board inside of the device that could result in a malfunction that could prevent or unacceptably delay 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 were requested to inspect their PIC 50 units for the affected serial numbers and return t |
| Quantity | 510 units |
| Distribution | Worldwide-USA, Australia, Belgium, Canada, Egypt, Finland, France, Germany, Ireland, Italy, Jordan, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sultanate of Oman, United Arab Emirates and the United Kingdom. |
| 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 |