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U.S. Department of Health and Human Services

Class 2 Device Recall reSETO Mobile App

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  Class 2 Device Recall reSETO Mobile App see related information
Date Initiated by Firm June 07, 2021
Create Date June 21, 2021
Recall Status1 Open3, Classified
Recall Number Z-1926-2021
Recall Event ID 88061
510(K)Number K173681  
Product Classification Computerized behavioral therapy device for psychiatric disorders - Product Code PWE
Product reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Code Information UDI Codes: reSET-O Mobile App, iOS (01) 10851580008118 (10) 1 reSET-O Mobile App, Android (01) 10851580008125 (10) 1 
Recalling Firm/
Manufacturer
Pear Therapeutics, Inc.
201 Mission St Ste 1450
San Francisco CA 94105-1882
For Additional Information Contact Jamie Nesbitt
415-349-5171
Manufacturer Reason
for Recall
Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin.
FDA Determined
Cause 2
Software design
Action On 05/20/2021, the Recalling Firm communicated via email an initial "URGENT: MEDICAL DEVICE RECALL" Notification with an amended/follow-up Notification Letter sent on or about 06/07/2021 informing customers that between 08/10/2020 and 04/30/2021, patients with a urine drug screen (UDS) logged into the Recalling Firm's database received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positive UDS results should not have resulted in access to a wheel spin. Customers are also being informed that there are no actions required for the safe handling of the corrected product. A software release was issued on 04/30/2021 to return the products to their intended operation. Given the potential for reduced clinical effectiveness, Healthcare Providers are encouraged to review patients that have a positive urine drug screen logged to ensure that the patient receives any treatment or counseling necessary to support the patient's treatment. Customers are asked to complete and return the "REPLY FORM" via Fax at 415-458-2700 (Attn: Yuri Maricich) or email to postmarked@peartherapeutics.com. For questions or further assistance, call 1-833-697-3738 (available weekdays 8:00 a.m. - 8:00 p.m. EST)
Quantity in Commerce 3,370 units
Distribution U.S.: AZ, CA, DE, FL, IL, IN, KY, MA, MD, MN, NC, NY, OH, TN, WA, and WI O.U.S.: N/A
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = PWE and Original Applicant = Pear Therapeutics, Inc.
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