The Recall Desk
HighFDA (Devices)·Z-2383-2021·Announced 2021-09-08

CoolSculpting Elite System Software Error May Misreport Thermal Events

The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II device recall involves a software malfunction in thermal event detection with potential for patient harm from either false reporting or failure to report actual thermal events. However, no illnesses or injuries have been reported in the source material, which per the rubric limits the severity score to High (3).

Plain-English summary

Zeltiq Aesthetics is recalling CoolSculpting Elite System devices due to an error in the thermal event detection and reporting software. The error messaging system can potentially cause two problems: reporting a thermal event error when none occurred, or failing to report a thermal event or other error codes.

If a thermal event error is incorrectly reported, users may re-treat the affected anatomic area within 24 hours unnecessarily, subjecting patients to additional thermal exposure. If a thermal event is not reported, users may continue treating without awareness that a thermal malfunction has occurred, potentially exposing patients to uncontrolled thermal conditions.

Approximately 911 to 1,105 CoolSculpting Elite Systems are affected, distributed throughout the United States and internationally. Affected models include CS-S3-002-D-00 and CS-S3-002-D-00_R with software releases 2.0, 3.0, 3.0.1, and 3.0.2.

The recalled product

Product
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
Manufacturer
Zeltiq Aesthetics, Inc
Category
Medical Device — Aesthetic Device
Hazard
  • thermal-event-misreporting
  • software-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • SW release 3.0
  • SW release 3.0.1
  • SW release 3.0.2 Serial Numbers: U.S.: D012020134001
  • D012020134009
  • D012020134014
  • D012020134015
  • D012020142001
  • D012020142002
  • D012020142003
  • D012020142004
  • D012020142005
  • D012020142006
  • D012020142007
  • D012020142012
  • D012020142013
  • D012020142014
  • D012020142015
  • D012020142016
  • D012020148001
  • D012020148002

Distribution

Distributed in 43 states:

  • AL
  • AR
  • AZ
  • CA
  • CO
  • CT
  • FL
  • GA
  • HI
  • IA
  • ID
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MD
  • MI
  • MN
  • MO
  • NC
  • ND
  • NE
  • NH
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • SC
  • TN
  • TX
  • UT
  • VA
  • VT
  • WA
  • WI
  • WV
  • WY

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