Events

Recall of Device Recall Physician Engineered Products, Inc

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Physician Engineered Products, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71803
  • Event Risk Class
    Class 2
  • Event Number
    Z-2486-2015
  • Event Initiated Date
    2013-08-31
  • Event Date Posted
    2015-08-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139124
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Unit, neonatal phototherapy - Product Code LBI
  • Reason
    Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions.
  • Action
    Physician Engineered Products, Inc. sent an Bright Embrace Recall notification dated September 10, 2013, to notify customers of the recall of the Bright Embrace . PEP is issuing a Return Authorization to you. Upon receipt PEP will reimburse to you: 1) The cost of the device(s) 2) Shipping costs-both from and to PEP For further questions please call (207) 935-1256.

Device

Device Recall Physician Engineered Products, Inc
  • Model / Serial
    Serial Numbers: 1002565 1002579 1002632 1002644 1002655 1002688 1002689 1002736 1002746 1002753-1002762 (10 units) 1002768-1002788 (21 units) 1002791-1002805 (15 units) 1002807-1002813 (7 units) 1002816-1002823 (8 units) 1002825-1002833 (9 units) 1002835-1002836 (2 units) 1002850-1002865 (16 units)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : CA, CO, FL, KY, MA, MD, NM, PA, TN, TX and VA., and to the countries of : Egypt, Honduras, Saudi Arabia and Singapore.
  • Product Description
    Bright Embrace, a Single Bili Light for newborn phototherapy || Distributed by: Physician Engineered Products, Inc., Model SBL60
  • Manufacturer
    Physician Engineered Products, Inc.

Manufacturer

Physician Engineered Products, Inc.
  • Manufacturer Address
    Physician Engineered Products, Inc., 103 Smith St, Fryeburg ME 04037-1182
  • Manufacturer Parent Company (2017)
    Physician Engineered Products Inc
  • Source
    USFDA