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U.S. Department of Health and Human Services

Class 2 Device Recall Pentacam

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 Class 2 Device Recall Pentacamsee related information
Date Initiated by FirmJuly 08, 2022
Create DateSeptember 02, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1672-2022
Recall Event ID 90661
510(K)NumberK201724 
Product Classification Device, analysis, anterior segment - Product Code MXK
ProductPentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Code Information Software version: 1.26r26 and 1.26r27 Model Number: 70020 UDI-DI Code: 04049584025357 Serial Numbers: 70020 0111 0201 70020 0211 0201 70020 0311 0211 70020 0711 1230 70020 1211 0201 70020 1321 1211 70020 2411 0211 70020 2911 1250 70020 3511 0211 70020 3801 0230 70020 4701 0210 70020 4811 1250 70020 5411 0211 70020 5701 0210 70020 6611 1230 70020 6621 1211 70020 7011 0201 70020 7511 1230 70020 8021 1290 70020 8701 0210 70020 9011 0201
FEI Number 3002807782
Recalling Firm/
Manufacturer		 Oculus Optikgeraete GMBH
Munchholzhauser Str. 29
Wetzlar Germany
For Additional Information Contact
425-6709977
Manufacturer Reason
for Recall		Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
FDA Determined
Cause 2		Software design
ActionOn 07/08/2022, OCULUS GmbH issued an "Urgent safety information Corrective Action " Letter to its subsidiary OCULUS Inc via UPS express which identifies a software error in the software version 1.26r26 and 1.26r27 in the IOL calculator of the Pentacam software. Corrective measures to be taken: A software update to version 1.26r28 must be performed on all computers used and affected in connection with the Pentacam and additional workstations. Users should refrain from using the printout of the IOL calculator for affected installations until after the software update has been carried out. For questions or support - contact OCULUS Inc Service Team at 425-670-9977 or email service@oculususa.com or fsca@oculus.de
Quantity in Commerce21 systems with affected software
DistributionU.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WY O.U.S.: N/A
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MXK
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