Device recall

Z-2108-2021: 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60…

FDA device recall · Class III · Mindray DS USA, Inc. dba Mindray North America

Key facts

Recall number (Z-number) Z-2108-2021
Recall event 88209
Product 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
Product code MSX
Recalling firm Mindray DS USA, Inc. dba Mindray North America
Recall class Class III
Status Terminated
Termination date Aug 11, 2022
510(k) numbers K193391
FEI number 2221819

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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