ROSA(TM) Robotized Stereotactic Assistant recall
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used…
Why was ROSA(TM) Robotized Stereotactic Assistant recalled?
Replacement of units lacking an updated device approval.
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?
Serial Numbers: RO 10 009, RO 10 011, RO 10 014, RO 13 023, RO 13 027, RO 14 031, RO 14 033, RO 14 035, RO 14 038, RO 14 039, RO 14 040, RO 14 041, RO 14 043, RO 15 044, RO 15 045, RO 15 046, RO 15 050, RO 15 051, RO 15 052, RO 15 053, RO 15 054, RO 15 058, RO 15 059, RO 15 060, RO 15 061, RO 15 063, RO 15 064, RO 15 067, RO 15 069
- Product
- ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used…
- Recalling firm
- MEDTECH SAS
- Quantity
- 29 units
- Distribution
- US Distribution
- Recall date
- June 13, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)