Sunell Receives FDA Warning Letter

Published Mar 16, 2021 15:06 PM

The US FDA has sent a warning letter to Sunell due to its sales of "adulterated and misbranded products", i.e. its widely relabelled Panda Cams.

In response, Sunell has taken down the problematic marketing and told IPVM "no more marketing multi-people scanning for fever cameras."

IPVM Image

** **** ******, **** ********:

  • *** *** ******* ******
  • ***** *** *** ***** ****** ********
  • ********* "** ** ** ******" ************ scanning ******
  • ****** *********** ******* ******** ****** ********
  • *** ****** ******* ***********
  • ****** ********

FDA ****** ******* ****** ** ****** *** "*********** *** ********** ********"

*** *** *** ****** ******** ******** ****** *** ******* ******* ******* marketing *** ******* ** **** ******** people **************.

IPVM Image

**** ******* ***** *** *** ****** similar ******* **** ***** ******* ******* ****** *********, ** **** ******** ******* **** month.

"Panda ***" ****** *****

******'* "***** ***" *** ****** **** OEMed ********** *** ******** *** *** easily ** ******** ********** *** ** its ****** ****** (*.*. ***** **** and ****).** ***** ** ************ *********** ** ** **** ***** relabeled *** ***** ***, *** **** widely ******** ** ***** ** **** security ****** ******** *****.

IPVM Image

2 ***** ****** ******* ****** ****** ********

******** ******'* ***** *** ** *** product **** ** **** ****** ***** and ************, *** ***'* ******* ****** also ******* ** ******'* "*********** ********* Thermographic ******* ****** ******" (**-***-*) *** "** ***** ********* ******* Camera **** ********** *********" (**-***-*-*). **** ** ***** ******* **** advertised ******** *********, ** ** ** targets *** *** ****** *** ** targets *** *** ******.

IPVM Image

***** *** ****** **** ******** ****** after *** ***** *** (** **** 2020 *** ***** ****), ***** ** likely *** **** **** *** **** as ************* **********.

Sunell ********* "******** *********" (** ** ** ******) ********* ******

** *** ****, ************* ***** *** *** ******* *** that ******'* ********* ** ******** ******** people (** **** ***** ** ** 45 ******) **** ************* ************** ******** ** ***** ******* *** conflicted **** *** *** *********** ***************.

****** *** ********** **** ********* ****** showing *** ****** ******** ** ** 45 ****** ** * ****.

IPVM Image

*** ***** ***'* ******* (************) *********** ****** ******** "** ** 45 *******."

IPVM Image

** *** **** *******, ****** ****** an ***** ** ****** ** ****** being ************** *******.

IPVM Image

********, ******'* ********* ********* ******** **** its *** *********** **********, ***** *** subjects ** ******** *** ****** ** a ****** **** ****, ******* ** walk **** *** *********, *** ****** straight ****** *** ******.

IPVM Image

*** *** *** *** ******** ******'* aggressive ********* ****** *** **** *** company * ******* ****** ***** ***** claims.

Not *** *** ********

*** ***, ***** *** ****, *** repeatedly *** ********** ****** ******* ******* systems ********** ******* *** ******** * ****. **** ** *** new ******** *** ****** *** **** thermal ******* ****** ********* ** ********.

Relabellers ********* ***** "********" *********

**** ********* ********* ******* "********" ****** screening ******* ** ******'* *********'* ********* materials. * *** ******** ** ********* faked ***/** ******* ********* ********* *** examined *****.

*****

***** *** **** ***** ********* ******** people ******** *** ****** ******** ******** screening *********** *** *******, **** ** **** ******* ***** (captured *****), **** **** ***** ** a ***** ** ***** ******** ****** are ******* ** ****:

IPVM Image

***** ******** * ***** ***** ******* * ********* ***** **** ****** 2020:

IPVM Image

******

******'********** ***************** ***** ** ********* ******** ***** of ******** ****** ***** *******. ******** people ** **** ***** **** **** on ** *****, ***** ***** ******** an ******** ****, ********** ***** *** Panda *** **** *** ******* ***** canthus ******** *** **** ******** ********. Further, *** ***** ***** ***** ** people **** ***** ***** ******* ****/****** away **** *** ******.

IPVM Image

*****, ****** ***** **** *** ****** can ****** ** ** ** *******.

IPVM Image

***********

************** **** ***** ******** ********* ** up ** ** ******, *** **** that **** *** ** ******. ***** on ****'* **** ***** ** ********* thermal ******** *******, ***** *** *********** challenges *** ********** ********* *** *********** of ****** ********, **** **** ** people *** ******.

IPVM Image

********

************ ****** ******** ****** ********* (**-** people ** ****). ** ****** *** Panda *** ** * "****** ******" ***** ****** *** ****** ** top ** * ******* ****. ***** DuThermX's ********* **** *** ****** ** "capable ** ******** **-** ******* **************," its ****** ****** ******* ***** **** people ****** ***** *** ******** **** either ** * ****** ** ****** lane *************. *****, **** "******** ****** detection" ***** ******* **** *********** **********.

IPVM ImageIPVM Image

FDA ********** ***** ***********, *** ****** ****** *****

*** *** *** ***** ******* ******* to *** **********, *** **** ** only ***** ** * ****** ********** that ***, ** ***, ******** * similar ******. ********, ***** **** ******** under ***** ********** *****, *** ********* ******* ********** *** *** *** *** **** reasons ****** ** ******. *****, ********'************* *********** ***** "******** ****** *********." Other ********* **** *** **** ***** blatantly ***** *********** (**** ** ***** specified ** **** ******) **** *** received ******* ********* ***** ***'* ******* ****** ********.

*** **** ** ******* ******* ****** to *********** ** * ***** ***** because *********** *** *********** *** **** of *** ****** ***** ** ***** cameras ** ***-*****. ** ******** ****** risk, *** *** **** *************** ****** the ********* ********* ** *** ****** relabellers *** *** ***********.

Sunell ********

**** ********* ***** *** *** ******* letter, ****** **** ****:

****** *** ********* ******** *** ******* letter *** **** **** ** ******** respond ** **** ** ********. ** the **** ****, *** **** *** already **** ********** ** ******* *** issues *** *** ******** ** **. We've ******* *** ************ ** *** FDA ******* *** ******* *** ******** descriptions *******. ***** **** ** ** more ********* *****-****** ******** *** ***** cameras.

******, ** ** ***** **, ****, the * ******** ****** ******' ****** webpages ** ****** ***** *****-****** *********.

** ***** **, ****** ****** **** IPVM *** ************* ******** *** ***, ********* ****** *** "removed *** ******* *** *********** ********* and ******* ***********" ****** * ***** of ********* *** ******* ******, ********* screenshots ** ******'* ******* ******* ***** the *******.

Comments (7)
UI
Undisclosed Integrator #1
Mar 16, 2021

**** ****** ****** ***** ****. ** pun ******** 🤣😂

UM
Undisclosed Manufacturer #2
Mar 16, 2021

**** *********. *************, *****'* *** ****** of **. ********* *********** ******** ** ad-dependent ** ****** *****-**** ** ******** makers *** *******. ** **** ******** it's ******** ***** *** *** ******, too- ****** *** ** ***** ****** it **** ******** ** ********.

(1)
Avatar
Ryan Anderson
Mar 16, 2021

*** *** ***** ****** ***** ****** this *****?

JH
John Honovich
Mar 16, 2021
IPVM

** *** **** ** *** ****, not **** ***** **** *** ********* greatly ******* ***** *** *****.

* ** ***** *** *********** ******* is ** *** ****** ***** ******* last **** ******** ** *****-****** ******** (which ** **** ***** *** ******* Sunell *********** **** ****), **** *** should **? *** *** ******** ** sue *** * ****** ** *** damages **** ***** * ******* **** violates *** ***********?

(2)
UM
Undisclosed Manufacturer #2
Mar 17, 2021

*** *** ******** ** *** *** a ****** ** *** ******* **** using * ******* **** ******** *** regulations?

*'* **** *****'* * **** **** for ***** ** *** ****** ** go ******* *** ****, ******* *** expense ** ***** **. *** **'* dependent ** *** ****** ***** **** to ***** ********** ***** *** ********* they **** ***** *** ***** ** by *** ***** *****. **** ** facility ******** *** ****** ***** ******* might ** **** ******** ** ** that, ************ **** *** ******** ***** down *** *** **** *** **** solutions **********.

*'* **** **** ******* ******** *** now **** **** **** **** *** issue ***** **** (***** ** *** same **** ******* ** ***** ****** black ***** ** ******* *** ***** the ***** ** ****** *** **** them ** *** ********).

(1)
JH
John Honovich
Mar 17, 2021
IPVM

*** **'* ********* ** *** ****** going **** ** ***** ********** ***** and ********* **** **** ***** *** taken ** ** *** ***** *****. Lots ** ******** ******** *** ****** board ******* ***** ** **** ******** to ** ****

* ***** ***** ****, **** *.*.,*** ********** **** **** ****** $***,*** of ********* *** ***** *******, ****'* ** ******* **** ** being ***** (*** ********* *** **********) but **** ***** **** **, ****** than ***** ***** *******.

(1)
JH
John Honovich
Mar 17, 2021
IPVM

******: ***** *** ******* *** *******, removing ***** ****** *** ****** *** video ******* **** *** *** ********** *** ******* ** ******* *** individual ** * ****:

IPVM Image

**** ** **********. ***** ***** * year ****** ****** ** *** ***** products ***** ** *** '*******' ** screen ****** ** ****** ** **** and *** **** **** **** ***** money, **** ** *** *** '***, actually ** **** ********* ********* *** individual ** * ****.'

(1)