# FDA recall Z-1027-2026

> **Remote Diagnostic Technologies Ltd.** · Class II · device recall initiated 2025-11-26.

## Product

Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R.    USB 2-Channel IBP Module, REF: 01-2017.    Used with User/Operator Manual

## Reason for recall

Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.

## Distribution

Worldwide - US Nationwide distribution including in the states of AZ, VA, FL, CA, TX, NM, IA, NJ, TN, OH, KS, IN, NC, IL, WY, WI, NV, NY, NE, PA, AL, MA, GA, MO, CO, OK, KY, OR, MS, MI, HI, WA, UT, WV, ID, ND, NH, MN, MT, ME, MD, DE and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE, IL, SG, CA, IE, TH, NL, MY, AT, DK, RO, CH, IS, PT, NO, HK, PL, KY, OM, CZ, SI, SL, GI, ZA, AF, SE, FI.

## Key facts

- **Recall number:** Z-1027-2026
- **Recalling firm:** Remote Diagnostic Technologies Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-26
- **Report date:** 2026-01-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Farnborough, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1027-2026

## Citation

> AI Analytics. FDA recall Z-1027-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1027-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*