Class 2 Device Recall Philips Smarthopping 2.0 AP 1.4 GHz

• Date Initiated by Firm: December 12, 2025
• Date Posted: January 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1033-2026
• Recall Event ID: 98158
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
• Code Information: Model No. 867216; UDI [Serial No.]: , (01)00884838099876(21)DK32800791[DK32800791], (01)00884838099876(21)DK32800825[DK32800825], (01)00884838099876(21)DK32800918[DK32800918], (01)00884838099876(21)DK32800947[DK32800947], (01)00884838099876(21)DK32801055[DK32801055], (01)00884838099876(21)DK32801076[DK32801076], (01)00884838099876(21)DK32801098[DK32801098], (01)00884838099876(21)DK32801120[DK32801120], (01)00884838099876(21)DK32801188[DK32801188], (01)00884838099876(21)DK32801197[DK32801197], (01)00884838099876(21)DK32801225[DK32801225], (01)00884838099876(21)DK32801235[DK32801235], (01)00884838099876(21)DK32801252[DK32801252], (01)00884838099876(21)DK32801306[DK32801306], (01)00884838099876(21)DK32801338[DK32801338], (01)00884838099876(21)DK33402127[DK33402127], (01)00884838099876(21)DK33402141[DK33402141], (01)00884838099876(21)DK33402210[DK33402210], (01)00884838099876(21)DK33402281[DK33402281], (01)00884838099876(21)DK33402309[DK33402309], (01)00884838099876(21)DK33402345[DK33402345], (01)00884838099876(21)DK33402358[DK33402358], (01)00884838099876(21)DK33402363[DK33402363], (01)00884838099876(21)DK33402364[DK33402364], (01)00884838099876(21)DK33402437[DK33402437], (01)00884838099876(21)DK33402526[DK33402526], (01)00884838099876(21)DK33402553[DK33402553], (01)00884838099876(21)DK33402569[DK33402569], (01)00884838099876(21)DK33402630[DK33402630], (01)00884838099876(21)DK33402653[DK33402653], (01)00884838099876(21)DK33402657[DK33402657], (01)00884838099876(21)DK33402737[DK33402737], (01)00884838099876(21)DK33402805[DK33402805], (01)00884838099876(21)DK33402894[DK33402894], (01)00884838099876(21)DK33402955[DK33402955], (01)00884838099876(21)DK33403058[DK33403058], (01)00884838099876(21)DK33403144[DK33403144], (01)00884838099876(21)DK33403145[DK33403145], (01)00884838099876(21)DK33403209[DK33403209], (01)00884838099876(21)DK33403222[DK33403222], (01)00884838099876(21)DK33403235[DK33403235], 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• FEI Number: 3016618143
• Recalling Firm/ Manufacturer: Philips North America Llc; 222 Jacobs St; Cambridge MA 02141-2289
• For Additional Information Contact: Philips Customer Services; 1-800-722-9377
• Manufacturer Reason for Recall: It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
• FDA Determined Cause: Software design
• Action: An URGENT Medical Device Correction notice, dated December 2025, was mailed to consignees. Risk mitigations to prevent the failure of devices to transmit data to central stations via the Smart-hopping network are outlined in the provided notification. The notice instructs consignees to share the provided communication with all clinical staff to review and understand, and to place the notice with documentation for affected devices. A Philips representative will contact consignees to arrange a software upgrade to E.10.03 (5.0.19.3) or greater, to correct the recall issues. Consignees with any questions should contact their local Philips representative or call 1-800-722-9377.
• Quantity in Commerce: 13,470 Units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC 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.