HS Hi-r NEO 900a recall: Software Issue
HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular…
Why was HS Hi-r NEO 900a recalled?
software error in the central control unit of the floor stand.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
The Error only occurs in combination with the following floor stands FS 2-21, FS 2-25, FS 3-45 with the software REF 615 586 in the versions 10.1.xx to 11.3.xx 1. Product: FS 2-21, Reference # 615 510 Serial # 101 to 360, SW-Version: 10.1.xx to 11.3.xx 2. Product: FS 2-21, Reference # 615 510, serial # from 361 3. Product: FS 2-25, Reference # 615 550, Serial # 101 to 376, SW Version: 10.1.xx to 11.3.xx 4. Product: FS 2-25, Reference # 615 550, Serial # from 377 4. Product: FS 3-45, Reference # 615 705, Serial #from 101
- Product
- HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular…
- Recalling firm
- Haag-Streit USA Inc
- Quantity
- 0
- Distribution
- US in the state of OH
- Recall date
- September 11, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)