Z-1809-2014 Class II Terminated
Recalled by Nellcor Puritan Bennett Inc. (dba Covidien LP)
— Boulder, CO
FDA device recall Z-1809-2014 was initiated by Nellcor Puritan Bennett Inc. (dba Covidien LP) on June 4, 2014 and is designated Class II. Reason for recall: In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. Howeve… The recall status is terminated (terminated July 11, 2016). Affected quantity: 7371.
Recall Details
- Product Type
- Devices
- Report Date
- June 25, 2014
- Initiation Date
- June 4, 2014
- Termination Date
- July 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7371
Product Description
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities
Reason for Recall
In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus there is a necessity to move the patient to another ventilator.
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia., and the countries of Canada and Japan.
Code Information
Display part number 4-079056-00; serial number 4200000001 to 3510012377 that have a 9.4 display. Lots 1032H,1041H,1042H,1043H,1008J,1009J,1010J,1018K,1019K,1020K,1021K,1022K,1023K,1030L,1031L,1032L,1033L,1034L,1035L,