Device recall

Z-1814-2020: X12+ and patient cable for the X12+ Telemeter with the following device name…

FDA device recall · Class II · WELCH ALLYN, INC/MORTARA

Key facts

Recall number (Z-number) Z-1814-2020
Recall event 85297
Product X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP, PAT CBL 4WIRE AHA SNAP HC.
Product code DPS
Recalling firm WELCH ALLYN, INC/MORTARA
Recall class Class II
Status Terminated
Termination date Feb 9, 2026
510(k) numbers K974149
FEI number 2183461

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 100–999 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

Browse all FDA device recalls (products)