Reported Mar 29, 2017 · Terminated
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Haag-Streit USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Haag-Streit USA Inc · 3535 Kings Mills Rd · Mason, OH · 45040-2303
Is this the product you have?
- EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
- Lot codes and dates
Model # 7220374 EyeSuite DICOM Option7220379 DICOM License
- BQ 900 LED S/N3682
- BQ LET Table S/N10038
- BX 900 LED w/Digital EyeSuite S/N10016
- CM 900 S/N354 & 491
- IM 900 / BQ 900 LED S/N
91950361136314631473148315056031312412 & 3011
- License Only S/N
030113210BP5P922561772414063204230623142514308712462395 & 1063
- Lenstar S/N
78 of 78 codes
167285332416469656878113411361197131313321607202620292030212621272128230823422343234623472349235023522353235523622387238823932686275828712901297630783084317032542021332025791298205521182737221485539639999124620222051227426912755
- Octopus 300 S/N
424233303735 & 1506
- Octopus 600 S/N
135246433434443708709710955956957958 & Demo
- Octopus 900 S/N
2968178420232140223728832884288629673010328637531784128619372763277837463139281311431239128722332373240625662567278028892926320028902024158216191647217425862624300630093011 & 3372
- Amount recalled
- 163 units
Where it was sold
- Nationwide
Why it was recalled
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
This product could cause temporary or reversible health problems — stop using it.
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