FDA Medical devices recall ·
Philips Telemetry Monitor 5500 1.4 GHz recall
- Recall number
- Z-2579-2026
- Date
- (initiated June 5, 2026)
- Company / brand
- Philips North America Llc
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 909 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 867232. UDI-DI: (01)00884838102842. Software Version Number: 4.0.0.0. Serial Numbers: US001A002F, US001A00AW, US001A00C9, US001A00EW, US001A00F0, US001A00GM, US001A00N4, US001A00PB, US001A00PZ, US001A00R1, US001A00UE, US001A00VU, US001A00Z4, US001A013T, US001A018A, US001A018R.
Distribution
US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.
States: Arizona California Colorado Indiana Massachusetts Michigan Minnesota Pennsylvania South Dakota Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2579-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.