Powers Medical Devices, LLC: 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.

Recall number

Z-0395-2016

Recalling firm

Powers Medical Devices, LLC

Product

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.

Status

Open, Classified

Initiated

2015-10-01

Posted

not on file

Terminated

not on file

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).

Root cause

No Marketing Application

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.

Quantity

Total of 128 units

Distribution

Nationwide Distribution.

Lot, serial or model codes

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);

510(k) numbers

["K151050"]

PMA numbers

not on file

Product code

HCC

Firm FEI

3009199231

Firm city

Delray Beach

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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