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No image published for this recall

M8 and S8 Lead Adaptors

Official notice

27 Jun 2021

Last checked

27 Jun 2021

High riskACCC

An official ACCC notice concerns M8 and S8 Lead Adaptors. Magnetic Resonance Imaging (MRI) poses a hazard to consumers who are implanted with S8 or M8 Lead Adaptors. Consumers with 'MR Unsafe' implants should not be scanned. If users are unaware that the lead adaptors are 'MR Unsafe' they may provide incorrect information to medical staff and this may result in a serious injury. Published 2021-06-27.

What to do now

Emergo Australia will directly contact implanted consumers to provide a new 'MR Unsafe' implant card. For further information, contact Emergo Australia by phone on 02 9006 1662.

Recall number

9ffcc18c-f10d-4f66-8690-4934562b0424

Official notice

2021-06-27

The hazard

Magnetic Resonance Imaging (MRI) poses a hazard to consumers who are implanted with S8 or M8 Lead Adaptors. Consumers with 'MR Unsafe' implants should not be scanned. If users are unaware that the lead adaptors are 'MR Unsafe' they may provide incorrect information to medical staff and this may result in a serious injury.

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.

Artg Numbers

199081, 204062

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Affected products

Product 1

M8 and S8 Lead Adaptors Product codes: MADP2008-25(B) and SADP2008-25(B) ARTG 199081 (Emergo Asia Pacific Pty Ltd T/a Emergo Australia - S8 Lead Adaptor Kit - Electrode/lead, stimulator, implantable, neurological) ARTG 204062 (Emergo Asia Pacific Pty Ltd T/a Emergo Australia - M8 Lead Adaptor Kit - Electrode/lead, stimulator, implantable, neurological) Used with Spinal Cord Stimulation (SCS) Systems that are neuromodulation devices designed to deliver electrical stimulation for the treatment of chronic intractable pain of the trunk and/or limbs.

Risk / hazard

Magnetic Resonance Imaging (MRI) poses a hazard to consumers who are implanted with S8 or M8 Lead Adaptors. Consumers with 'MR Unsafe' implants should not be scanned. If users are unaware that the lead adaptors are 'MR Unsafe' they may provide incorrect information to medical staff and this may result in a serious injury.

Where it was sold

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

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products, Power supply and storage

App estimate

high

Recall details

Recall number

9ffcc18c-f10d-4f66-8690-4934562b0424

Classification

Pharmacy and medical products, Power supply and storage

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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