The Recall Desk
HighFDA (Devices)·Z-1814-2020·Announced 2020-05-06

Welch Allyn X12+ Telemeter and Patient Cable Recall for Defibrillation Safety

Welch Allyn is recalling X12+ Telemeters and patient cables because they may not meet defibrillation withstand requirements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device that may not meet safety standards for defibrillation withstand, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Welch Allyn, Inc/Mortara is recalling the X12+ Telemeter and associated patient cables. The specific device names involved include 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, and PAT CBL 4WIRE AHA SNAP HC. The recall covers 78,521 units distributed nationwide in the United States, including specific states and territories listed in the agency record.

The recall is being conducted because the impacted products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. This standard ensures that medical electrical equipment can withstand defibrillation without causing harm to the patient or malfunctioning. The affected model numbers are X12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51, and 9293-034-50.

Healthcare facilities and users of these devices should contact Welch Allyn for instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this recall.

The recalled product

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.
Manufacturer
WELCH ALLYN, INC/MORTARA
Category
Medical Device — Cardiac Monitoring
Hazard
Affected units
78,521

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Model Numbers: X12PLUS-XXX-XXXXX
  • 9293-017-50
  • 9293-017-51
  • 9293-026-50
  • 9293-026-51
  • 9293-034-50

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 10 recalled by WELCH ALLYN, INC/MORTARA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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