Philips Telemetry Monitor 5500 Device Reset Risk Recall
Philips Telemetry Monitor 5500 (Model 867232) may unexpectedly reset to default "NEW_DEVICE" state, causing loss of device configuration and disconnection from the PIC iX central monitoring system.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a medical device. The source text does not report any actual illnesses, injuries, hospitalizations, or documented adverse events—only a potential for configuration loss and communication failure. Per the rubric, Class II recalls without reported harm typically score 2 (Moderate).
Plain-English summary
Philips North America LLC is recalling Philips Telemetry Monitor 5500 1.4 GHz devices (Model Number 867232, Software Version 4.0.0.0) due to a potential for the device to reset to a default "NEW_DEVICE" state.
When this reset occurs, the device may lose its configuration and equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system. This communication loss could impact patient monitoring capabilities.
The recall affects 909 units distributed nationwide in Arizona, California, Colorado, Indiana, Massachusetts, Michigan, Minnesota, Pennsylvania, South Dakota, and Tennessee. Specific serial numbers are identified in the recall documentation.
Healthcare facilities and users with affected units should contact Philips for further guidance regarding identification of affected devices and remediation options.
The recalled product
- Product
- Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.
- Manufacturer
- Philips North America Llc
- Affected units
- 909
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 (15)
- US001A00AW
- US001A00C9
- US001A00EW
- US001A00F0
- US001A00GM
- US001A00N4
- US001A00PB
- US001A00PZ
- US001A00R1
- US001A00UE
- US001A00VU
- US001A00Z4
- US001A013T
- US001A018A
- US001A018R.
Distribution
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