Recall Z-2486-2015 ยท LBI Unit, Neonatal Phototherapy
Physician Engineered Products, Inc.
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
| Date | Aug 31, 2015 (initiated Aug 31, 2013) |
| Status | Terminated |
| Reason | Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110550 | BRIGHT EMBRACE MODEL SBL60 Physician Engineered Products, Inc., Feb 3, 2012 |