Z-2486-2015Class II

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

Name: Z-2486-2015 Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products...
Creator: Physician Engineered Products, Inc.
Published: 2013-08-31
License: https://open.fda.gov/license/

Physician Engineered Products, Inc. / initiated 2013-08-31 / Terminated / root cause: design

FDA source

Physician Engineered Products, Inc. began a recall of Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60 on 2013-08-31. FDA classified it as Class II and gives the reason as "Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2486-2015
Classification: Class II
Status: Terminated
Initiated: 2013-08-31
Posted: 2015-08-31
Terminated: 2015-09-02
Recalling firm: Physician Engineered Products, Inc.
Product: Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Product code: LBI Unit, Neonatal Phototherapy
Reason for recall: Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2486-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2486-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-08-31

Product code LBI

K110550Class IIBright Embrace Model Sbl60Physician Engineered Products, Inc. / cleared 2012-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)