Events

Recall of Device Recall Pacifier Activated Lullaby (PAL) System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Powers Medical Devices, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72436
  • Event Risk Class
    Class 2
  • Event Number
    Z-0395-2016
  • Event Initiated Date
    2015-10-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141008
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, biofeedback - Product Code HCC
  • Reason
    Pal unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
  • Action
    Powers Medical Devices, LLC intends to notify customers via certified U.S. Mail and supply the updated Instruction Manual via U.S. Mail or other tracked service. Instructions to customers include: 1) destroy the previous Instruction Manual, and replace it with the new one provided, 2) attach the new product label over the existing labeling without covering up the Model # and serial # of the device, 3) certify the destruction and replacement of the Instruction Manual nd replacement of the product label to the company using the form and self-addressed stamped envelopw provided.

Device

Device Recall Pacifier Activated Lullaby (PAL) System
  • Model / Serial
    Serial Numbers A1221, A1226 (Ship Date 07/2015);   Serial Numbers A1061, A1250, A1251 (Ship Date 05/2015);   Serial Number A1246 (Ship Date 04/2015);   Serial Numbers A1245, A1244, A1042, A1243 (Ship Date 02/2015);   Serial Number A1225 (Ship Date 01/2015);   Serial Numbers A1241, A1242 (Ship Date 12/2014);   Serial Number A1036 (Ship Date 11/2014);   Serial Numbers A1229, A1247, A1224 (Ship Date 10/2014);   Serial Numbers A1239, A1234, A1236, A1237, A1238, A1233, A1228, A1231, A1232, A1235 (Ship Date 09/2014);   Serial Number A1227 (Ship Date 08/2014);   Serial Number A1223 (Ship Date 07/2014);   Serial Numbers A1218, A1220 (Ship Date 06/2014);   Serial Numbers A1217, A1216, A1248 (Ship Date 04/2014);   Serial Numbers A1214, A1064 (Ship Date 03/2014);   Serial Numbers A1087, A1213 (Ship Date 01/2014);   Serial Numbers A1201, A1203, A1204, A1205, A1206, A1209, A1210, A1211, A1212, A1094, A1200, A1207, A1091, A1092, A1093, A1201 (Ship Date 12/2013;   Serial Numbers A1075, A1076, A1077, A1078, A1079, A1080, A1081, A1082, A1083, A1070, A1072, A1073, A1084, A1086, A1087, A1088, A1089, A1090, A1085 (Ship Date 11/2013);   Serial Numbers A1022, A1044 (Ship Date 10/2013);   Serial Number A1059 (Ship Date 09/2013);   Serial Numbers A1021, A1060, A1062, A1063, A1065, A1066, A1067, A1069 (Ship Date 08/2013);   Serial Numbers A1037, A1005, A1015, A1024, A1230, A1050, A1051, A1052, A1053, A1054, A1055, A1058, A1016, A1019, A1064, A1249 (Ship Date 07/2013);   Serial Numbers A1006, A1020, A1004, A1023, A1021 (Ship Date 05/2013);   Serial Numbers A1025, A1046, A1032 (Ship Date 04/2013);   Serial Numbers A1038, A1049, A1029, A1026, A1035, A1039, A1036, A1031, A1030, A1028, A1027, A1034 (Ship Date 03/2013);   Serial Number P11 (Ship Date 02/2013);   Serial Number P-7 (Ship Date 11/2012);   Serial Numbers A1013, P-8 (Ship Date 09/2012);   Serial Numbers A1043, P-6, A1041, P-9 (Ship Date 07/2012);
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.
  • Manufacturer
    Powers Medical Devices, LLC

Manufacturer

Powers Medical Devices, LLC
  • Manufacturer Address
    Powers Medical Devices, LLC, 1615 S Congress Ave Ste 103, Delray Beach FL 33445-6326
  • Manufacturer Parent Company (2017)
    Powers Medical Devices, LLC
  • Source
    USFDA