Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model
FDA device recall Z-2486-2015 · posted 2015-08-31 · Terminated
Recall details
- Recalling firm
- Physician Engineered Products, Inc.
- Reason for recall
- Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LBI
- Quantity affected
- 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.
- Date initiated
- 2013-08-31
- Date posted
- 2015-08-31
- Date terminated
- 2015-09-02
- Location
- Fryeburg, ME
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRIGHT EMBRACE MODEL SBL60 (K110550) | Physician Engineered Products, Inc. | 2012-02-03 |