CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report

Philips Smart-hopping 2.0 AP 1.4 GHz recalled by Philips North America

Philips North America is recalling Philips Smart-hopping 2.0 AP 1.4 GHz, distributed nationwide in the US. The recall was initiated on 16 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct/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;

Quantity recalled174

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0199-2027
FDA event ID: 99908
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 16 Sep 2026
FDA classified: 16 Oct 2026
Reported: 28 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Sep 2026	Recall initiated by company
16 Oct 2026	Classified by FDA	+30 days
28 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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).

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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;

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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