Telemetry monitors recalled over a failure to reconnect between access points
Philips North America is recalling 13,470 Smart-hopping 2.0 AP 1.4 GHz patient monitors because the MX40 could not reconnect to the PIC iX when signal strength changed quickly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a monitor that cannot reconnect can interrupt central monitoring of a patient, and no injuries are reported.
Plain-English summary
The Philips Smart-hopping 2.0 AP 1.4 GHz patient monitor, model 867216, is being recalled.
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.
The record lists 13,470 units, with UDI and serial number pairings listed in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
A monitor that cannot reconnect may stop sending patient data to the central station. The enforcement record reports no injuries. Facilities should follow Philips' instructions.
The recalled product
- Product
- Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Patient monitor
- Affected units
- 13,470
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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]
Distribution
Distributed nationwide across the United States.
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