Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use in and out of the hospital.

FDA device recall Z-0937-2011 · posted 2011-01-24 · Terminated

Recall details

Recalling firm

Welch Allyn Protocol, Inc

Reason for recall

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.

Action taken

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 component (including the screen display) are fully operation and undamaged. The letter further states "our analysis indicates that routinely doing such checks will likely lead to discovery of this malfunction as it occurs, and thus timely maintenance and repair". The distributors are advised to communicate this Product Alert to their customers if the devices were further distributed. For customers in US and Canada, distributors are advised to provide the electronic Excel file with customer's name, address, serial number and part number to WA2221@Stericycle.com. For customers in other countries, they are advised to provide information to PIC50Product Alert@welchallyn.com Consignees can call Welch Allyn at 800-289-2500 for any questions during normal business hours.

Root cause

Other

Status

Terminated

Product code

DRO

Quantity affected

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,

Date initiated

2010-09-17

Date posted

2011-01-24

Date terminated

2011-07-25

Location

Beaverton, OR

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