HIGH

Philips Recalls Patient Monitors Over Connectivity Issue

Philips recalled 13,470 Smart-hopping 2.0 AP Patient Monitors on December 12, 2025. The MX40 device failed to reconnect to the PIC iX under certain conditions, posing a high risk to patient monitoring. Healthcare providers should stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
December 12, 2025
Hazard Level
HIGH
Brand
Philips North America
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America Llc or your healthcare provider for instructions. Notification method: Letter

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recall affects Philips Smart-hopping 2.0 AP Patient Monitors, specifically Model No. 867216. These devices were distributed nationwide in the United States.

The Hazard

The MX40 device may not reconnect to the PIC iX when transitioning between access points if the signal strength changes rapidly. This connectivity failure can compromise patient monitoring.

Reported Incidents

There have been no reported injuries or deaths associated with this issue as of the recall date. The risk remains high due to the potential for disrupted patient monitoring.

What to Do

Immediately stop using the affected patient monitors. Contact Philips North America for further instructions and follow the recall notice sent by the manufacturer.

Contact Information

For more information, call Philips North America at 1-800-xxx-xxxx or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1033-2026.

Key Facts

  • Recall date: December 12, 2025
  • Quantity affected: 13,470 units
  • Model No. 867216
  • Hazard level: High

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Model No. 867216
(01)00884838099876(21)DK32800791[DK32800791]
(01)00884838099876(21)DK32800825[DK32800825]
(01)00884838099876(21)DK32800918[DK32800918]
(01)00884838099876(21)DK32800947[DK32800947]
+14 more
Affected States
ALL
Report Date
January 14, 2026
Recall Status
ACTIVE

Related Recalls

HIGH

Fresenius Kabi Vancomycin Injection Recalled Over Sterility Concerns

Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Fresenius Kabi Compounding Issues Recall of Vancomycin Injection

Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.

Fresenius Kabi Compounding
Lack of
Read more
HIGH

Pro Numb Tattoo Numbing Spray Recalled Due to cGMP Violations

Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.

PRO NUMB SENSITIVE SKIN
cGMP deviations
Read more