No image published for this recall

Boston Scientific Neuromodulation WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320 - safety alert

Official notice

21 Aug 2024

CriticalFDA

An official FDA notice concerns WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320. The notice reports a chemical exposure risk. Stop using the product and follow the official notice. Published 2024-08-21. Recall numbers: Z-2617-2024. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

77,674

Recall number

Z-2617-2024

Official notice

2024-08-21

The hazard

Chemical exposure risk

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Event Ids

94995

Recall Numbers

Z-2617-2024

Checked manually this time?

The app alerts you when a new official recall is published — no searching, no checking back.

Turn on recall alerts

Affected products

Product 1

WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320

Units affected

77,674

Risk / hazard

Chemical exposure risk

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

AE · United Arab Emirates

Affected area 3

AR · Argentina

Affected area 4

AT · Austria

Affected area 5

AU · Australia

Affected area 6

BE · Belgium

Affected area 7

BG · Bulgaria

Affected area 8

BR · Brazil

Affected area 9

CA · Canada

Affected area 10

CH · Switzerland

Affected area 11

CO · Colombia

Affected area 12

CZ · Czech Republic

Affected area 13

DE · Germany

Affected area 14

DK · Denmark

Affected area 15

ES · Spain

Affected area 16

FI · Finland

Affected area 17

FR · France

Affected area 18

GB · United Kingdom

Affected area 19

GR · Greece

Affected area 20

HR · Croatia

Affected area 21

HU · Hungary

Affected area 22

IE · Ireland

Affected area 23

IL · Israel

Affected area 24

IT · Italy

Affected area 25

JP · Japan

Affected area 26

LU · Luxembourg

Affected area 27

NL · Netherlands

Affected area 28

NO · Norway

Affected area 29

NZ · New Zealand

Affected area 30

PL · Poland

Affected area 31

PT · Portugal

Affected area 32

SA · Saudi Arabia

Affected area 33

SE · Sweden

Affected area 34

SG · Singapore

Affected area 35

SK · Slovakia

Affected area 36

TR · Turkey

Affected area 37

UA · Ukraine

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific Neuromodulation. Contact: Boston Scientific Neuromodulation Corporation.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

critical

Recall details

Recall number

Z-2617-2024

Event id

94995

Units affected

77,674

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
Something wrong on this page?

Related recalls

ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA17 Jun 2026

Brand match

Critical risk

Markets

UK
ELECTRONICS
Medium

a product listed in the official notice - safety alert

FDA22 Apr 2026

Brand match

Medium risk

Markets

UK
ELECTRONICS
Medium

Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09 - safety alert

FDA24 Sept 2025

Brand match

Medium risk

Markets

UK
ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA27 Aug 2025

Brand match

Critical risk

Markets

UK
ELECTRONICS
Medium

a product listed in the official notice - safety alert

FDA10 Sept 2025

Brand match

Medium risk

Markets

US
ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA5 Jun 2024

Brand match

Critical risk

Markets

UK
ELECTRONICS
Medium

a product listed in the official notice - safety alert

FDA21 Jun 2023

Brand match

Medium risk

Markets

US
ELECTRONICS
Medium

Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm - safety alert

FDA23 Nov 2022

Brand match

Medium risk

Markets

US
ELECTRONICS
Critical

a product listed in the official notice - safety alert

FDA3 Jun 2020

Brand match

Critical risk

Markets

US
ELECTRONICS
Medium

a product listed in the official notice - safety alert

FDA22 Apr 2020

Brand match

Medium risk

Markets

US
ELECTRONICS
Medium

a product listed in the official notice - safety alert

FDA7 Oct 2026

Brand match

Medium risk

Markets

US
ELECTRONICS
Medium

Computed Tomography X-ray System, Model: uCT 530 with software - safety alert

FDA7 Oct 2026

Brand match

Medium risk

Markets

US

Weekly recall digest

Get next week's recalls before you need them.

One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.

The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.

This recall was published 21 Aug 2024. The next one won't wait for you to search.

RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.