Philips North America LLC recalls Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following sy…
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Model
- 867232
- UDI
- (01)00884838102842. Software Version Number: 4.0.0.0
- Serial #
- US001A002F, US001A00AW, US001A00C9, US001A00EW, US001A00F0, US001A00GM, US001A00N4, US001A00PB, US001A00PZ, US001A00R1, US001A00UE, US001A00VU, US001A00Z4, US001A013T, US001A018A, US001A018R
What the firm is doing
Philips Medical notified consignees on about 06/05/2026 via "URGENT Medical Device Correction" letter. Consignees were notified of the issue and potential hazard and instructed to continue the use of the device but avoid touching the display while the device is booting up and provide this notification to all personnel who need to be aware within each organization or to any organization where affected product(s) have been potentially transferred. Philips will release new software which will correct this problem. A Philips representative will contact you to arrange for an upgrade to the new software.
DistributionShow detailsHide
US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2579-2026
- FDA 510(k) clearance · K242962The device's official FDA premarket clearance record
- FDA device classification · MHXOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1025The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Philips North America LlcSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm
