Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Summary
The FDA issued a Class II for Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216; by Philips North America. Reason: Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resul.
Details
Source
Device Recall
External ID
Z-0199-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Lot/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;
Quantity Affected: 174
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).
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-16
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
Philips North America has 141 FDA actions in our database, including 141 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America have FDA actions?
Philips North America has 141 FDA actions in our database, including 141 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0199-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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