Device recall

Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;

FDA recall source

Recall number

Z-0199-2027

Event id

99908

Status

Ongoing

FDA classification

Class II

Recalling firm

Philips North America

Report date

Oct 28, 2026

Posted

Oct 16, 2026

Initiated

Sep 16, 2026

Center classification date

Oct 16, 2026

Product code

MHX

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Reason

Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX).

Root cause

Software design

Quantity

174

Code info

Product/Model Number: 867216; UDI-DI: N/A; System Serial Numbers: DK61624330, DK61623830, DK61724824, DK61623802, DK61623826, DK61624101, DK61624082, DK61623910, DK61624187, DK51313245, DK61724472, DK61724620, DK61724590, DK61724461, DK61724725, DK61724679, DK61724684, DK51313645, DK51313455, DK61724814, DK61724747, DK61624235, DK61422548, DK52316132, DK61724553, DK61724957, DK61724756, DK61523178, DK61724502, DK61724860, DK61523117, DK61724577, DK61724376, DK61724566, DK61422553, DK61322150, DK61523070, DK61523270, DK52617072, DK61523151, DK61422454, DK53817745, DK52617073, DK61422674, DK61422973, DK61523211, DK61322124, DK61523272, DK61523248, DK51313320, DK61422463, DK61523260, DK61322137, DK61322337, DK61322253, DK61322375, DK61322380, DK61422762, DK61422868, DK61322122, DK61422851, DK61322283, DK61523658, DK61422848, DK61422884, DK61422897, DK61523409, DK61422808, DK61422736, DK61422806, DK61422763, DK61523517, DK61422957, DK61523383, DK61523442, DK61322227, DK61422843, DK61523495, DK61423030, DK61422949, DK61322271, DK61322127, DK60621383, DK60621482, DK61322213, DK60321063, DK60320788, DK60621426, DK60621646, DK61322238, DK60621223, DK60621517, DK61322379, DK52316002, DK60320966, DK60621224, DK60621197, DK60821808, DK60621565, DK60821916, DK60821936, DK60320570, DK60320720, DK60320768, DK60320506, DK60320537, DK60321057, DK60320711, DK60320892, DK60320761, DK60320544, DK60321033, DK60320571, DK60320759, DK60320484, DK60321044, DK60320839, DK60320419, DK60320437, DK60320474, DK54820263, DK60320601, DK60320592, DK54820262, DK54820037, DK54819845, DK54820134, DK54819871, DK54820272, DK60320874, DK54519084, DK54519572, DK54820343, DK54819876, DK52516932, DK54519153, DK53817766, DK54518977, DK52516923, DK54519018, DK53817821, DK54820004, DK54819819, DK54820101, DK54819922, DK54518948, DK52516510, DK54519031, DK54518951, DK54519115, DK52516754, DK52516873, DK52516766, DK53817862, DK52516569, DK52516783, DK52516933, DK54418622, DK52516533, DK52315958, DK53217276, DK52316143, DK53217187, DK53217154, DK52316114, DK53217197, DK54418453, DK53918024, DK54418698, DK54418600, DK54418588, DK54418881, DK54519407, DK54418598;

Distribution

US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Location

Cambridge, MA, United States