# FDA recall Z-2811-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-06-18.

## Product

Phillips Charging Station, Product #: 989803191021 - Product Usage: This charging station is used in the Expression MR400 MRI Patient Monitoring System (Model MR400) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner.

## Reason for recall

A problem has been detected with the Philips LI-Polymer rechargeable battery when used with its approved charging station and module charger. When the battery is inserted into a charger bay, the LED indicatory lights solid red and the battery will not charge. This may result from poor electrical contact between the battery and charger.

## Distribution

World wide distribution.    Firm reports distributing more product then quantity manufactured. Clarification requested. And received. Firm made error in counting number of batteries distributed.

## Key facts

- **Recall number:** Z-2811-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-18
- **Report date:** 2020-08-26
- **Termination date:** 2023-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2811-2020

## Citation

> AI Analytics. FDA recall Z-2811-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2811-2020. Source: US FDA. Licensed CC0.

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