Data Foundry

Medical device recalls 2026

Patient Information Center iX — Class II medical device recall Z-1156-2026

Ongoing recall by Philips North America, reported 2026-01-28, distributed nationwide. A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indicati

Recall numberZ-1156-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips North America, Cambridge, MA, United States
Recall initiated2025-12-22
Classified2026-01-22
Reported by FDA2026-01-28
DistributedNationwide (US)
Countries outside the USAT, BE, BR, CA, CH, CZ, DE, ES, FI, FR, GB, GR, HU, IN, IT, JO, JP, KR, NL, NO, PL, SA, SE, SG, TW, ZA
Reason classessoftware
UPC / GTIN / UDI-DI00884838127074
Serial numbers0021-1DNN-P, 0128-2WG5-0, 0247-7ELE-R, 0830-3RLW-W, 097K-7LPC-5, 0B3Z-2RHR-L, 0D2V-1BLC-8, 0D5Y-32PN-A, 0F2U-1BLC-H, 0J7W-31N5-2, 0L5F-0ZNF-J, 0M0V-6FKB-5, 0P6C-4TL3-D, 0R2W-1VNP-P, 0V2A-6DHP-0, 0Y5Z-7FHX-N, 107C-62PF-Y, 120T-17M9-A, 121L-1KG1-M, 133W-3UN7-B, 1366-7XLV-X, 144W-7RPJ-5, 1472-5WKF-X, 173C-20JM-J, 186W-1UP5-8 and 120 more
Model numbers00884838127074, 866389, 866390

Product

Patient Information Center iX; Software Version Number: 4.5.0

Reason for recall

A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1156-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.