Recall Z-0937-2011 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Welch Allyn Protocol, Inc
Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use in and out of the hospital.
| Date | Jan 24, 2011 (initiated Sep 17, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | On 9/17/10, Welch Allyn began sending out the Important Product Alert letter to all their direct consignees. On 9/24/2010, the firm sent out the letters to their distributors. The Product Alert letter informs the consignees of a low potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The consignees are advised to follow the instruction in the PIC 50 user's manual requiring routine shift equipment checks daily or at each shift change to minimize the likelihood of the malfunction from occurring. The checks ensure that the PIC 50 and its com |
| Quantity | 2002 units to US consignees and 1604 units to foreign consignees |
| Distribution | Worldwide Distribution -- US, including states: AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and countries of Australia, Austria, Belgium, Canada, China, Columbia, Cyprus, De |
| 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 |