Recall Z-2486-2015— Physician Engineered Products, Inc.

Name: FDA recall Z-2486-2015
Creator: U.S. Food and Drug Administration
Published: 2013-08-31

Class II · Terminated

Class II FDA medical device recall by Physician Engineered Products, Inc., initiated 2013-08-31, terminated 2015-09-02. It names one FDA 510(k) clearance: K110550. Product: Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60. Reason: Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions.

Recalling firm: Physician Engineered Products, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-31
Terminated: 2015-09-02
Firm location: Fryeburg, ME, United States

510(k) clearances named in this recall

1 on FDA's record

K110550 — BRIGHT EMBRACE MODEL SBL60Physician Engineered Products, Inc.·cleared 2012-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

Reason for recall

Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions

Data sourced from openFDA. This site is unofficial and independent of the FDA.