2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare

FDA device recall Z-0734-2023 · posted 2022-12-20 · Open, Classified

Recall details

Recalling firm

Fresenius Medical Care Holdings, Inc.

Reason for recall

(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm "Remove USB 2 Device".

Action taken

Fresenius issued Updated Urgent Medical Device Correction REV B Customer Notification letter (Field Action Number: FA-2020-09-W _REV B) to consignees that have CDX equipped machines on 07-27-2022 via USPS First Class Mail. Letter states reason for recall, health risk and action to take: First, a software issue in SW versions 2.72 and earlier. All machines should be updated to current software (SW version 2.74), pursuant to the July 20, 2021, letter. Second, hardware issue that affects only CDX machines. To reduce the chance of EMI causing a false Remove USB Device 2 alarm from occurring we suggest the following: " Insert a USB device in USB Port 2 that will continually draw current. For example, a blank USB memory stick or a USB powered card reader. o NOTE: DO NOT use passive USB devices in USB Port 2 that go into a suspended state drawing minimal/low current which can trip the sensing circuit. An example would be a USB corded optical mouse. Complete/Return the response form enclosed.

Root cause

Process design

Status

Open, Classified

Product code

KDI

Quantity affected

2008T with CDX= 70,552 2008T Bluestar with CDX= 25,205

Distribution

US Nationwide distribution.

Date initiated

2022-07-27

Date posted

2022-12-20

Location

Waltham, MA

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