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U.S. Department of Health and Human Services

Class 2 Device Recall Physician Engineered Products, Inc

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  Class 2 Device Recall Physician Engineered Products, Inc see related information
Date Initiated by Firm August 31, 2013
Date Posted August 31, 2015
Recall Status1 Terminated 3 on September 02, 2015
Recall Number Z-2486-2015
Recall Event ID 71803
510(K)Number K110550  
Product Classification Unit, neonatal phototherapy - Product Code LBI
Product Bright Embrace, a Single Bili Light for newborn phototherapy
Distributed by: Physician Engineered Products, Inc., Model SBL60
Code Information 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) 
Recalling Firm/
Manufacturer		 Physician Engineered Products, Inc.
103 Smith St
Fryeburg ME 04037-1182
For Additional Information Contact
207-935-1256
Manufacturer Reason
for Recall		 Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 97 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LBI and Original Applicant = PHYSICIAN ENGINEERED PRODUCTS, INC.
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