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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Smarthopping 2.0

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 Class 2 Device Recall Philips Smarthopping 2.0see related information
Date Initiated by FirmSeptember 16, 2026
Date PostedOctober 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0199-2027
Recall Event ID 99908
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductPhilips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Code Information 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;
FEI Number 3006648320
Recalling Firm/
Manufacturer		 Philips North America
222 Jacobs St
Cambridge MA 02141-2296
For Additional Information ContactPhilips Customer Services
800-722-9377
Manufacturer 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).
FDA Determined
Cause 2		Software design
ActionOn september 16, 2026, URGENT Medical Device Correction, letters were sent to customers. Actions to be taken: 1. Direct clinical attendance of the patient during transport, when this issue is most likely to manifest, should be considered if not currently a part of the clinical workflow. In the event a persistent No Central Monit technical alarm is noted at the wireless device or a No Data technical alarm is noted at the central monitor; a restart of the wireless monitor may restore central monitoring when the patient is in known good wireless coverage area. 2. Pass this notice to all those who need to be aware within your organization or to any organization where affected product(s) have been potentially transferred. Actions planned by Philips to correct the problem 3. Philips representative will contact you to arrange the software upgrade SH 2.0 AP 1.4GHz which will correct this issue. If you need any further information, please contact your local Philips representative, or call (800) 722-9377.
Quantity in Commerce174
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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