WaveWriter Alpha™ SCS System (Models SC-1216 / SC-1232)

Boston Scientific

Not determinedIndexed from FDA records

MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.

Don't schedule an MRI based on this page alone — your MRI team verifies every device.

What this means for you

MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
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For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

8/28/2013 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

8/28/2013 · View on FDA.gov

⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.

Regulatory Info

510(k) NumberK024048 ↗
Clearance Date1/5/2003
Product CodeFGE
✅
All Recalls Resolved

2 past recalls — all corrective actions completed

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Neuro

Body Region

Spinal Cord Stimulators

View Manufacturer MR Safety Documentation

Official Boston Scientific guidelines

MRI Scan Parameters

Max Field Strength1.5T

MRI Conditions

Full-body MR Conditional at 1.5T. Toggle the device into "MRI Mode" via Bluetooth or patient remote prior to entering the magnet room.

Clinical Warnings

MRI conditional with specific protocols. Some models full-body MRI, others head-only or limited. Verify model-specific conditions.

Post-MRI Notes

Interrogate device after MRI to verify settings.

🔔 Get Recall Alerts for WaveWriter Alpha™ SCS System (Models SC-1216 / SC-1232)
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Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.