QiG Group Recalls Algovita Implanted Pulse Generators Due to Connection Issues
QiG Group LLC is recalling 34 Algovita Implanted Pulse Generators because they may fail to connect to external devices unless held very close, preventing reprogramming and recharging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a risk-of-harm product (implanted medical device) where the inability to recharge or adjust parameters could lead to adverse health consequences, but no injuries or illnesses have been reported in the source text.
Plain-English summary
QiG Group LLC is recalling 34 units of the Algostim LLC Algovita Implanted Pulse Generator stimulator, Model 2412 (2 x 12 channel). The recall involves specific serial numbers distributed in Germany and Luxembourg.
The recall is due to suboptimal performance in establishing a connection to external devices unless they are brought into close proximity, as close as 5 cm. This issue may prevent users from reprogramming the stimulator, adjusting stimulation parameters such as intensity and program selection, or recharging the device.
Patients with these specific implanted pulse generators should contact their healthcare provider or the recalling firm for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
- Manufacturer
- QiG Group LLC
- Affected units
- 34
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 (20)
- Serial Numbers: 03EDB5
- 03EDD9
- 03EDDA
- 03EDDB
- 03EDDD
- 03EDE0
- 03EDE4
- 03EDF5
- 03EDF6
- 03EDFA
- 03EDFC
- 03EDFF
- 03EE07
- 03EE08
- 03EE0A
- 03EE0D
- 03EE0E
- 03EE12
- 03EE13
- 03EE1A
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by QiG Group LLC 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 3 products in this recall →Related recalls
Same manufacturer · QiG Group LLC
See all →- HighQiG Group Recalls Algovita Implanted Pulse Generators Due to Connection Issues
FDA (Devices) · 2016-03-30
- HighAlgovita External Pulse Generator Recalled for Connection Issues
FDA (Devices) · 2016-03-30
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