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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-1674-2022
Recall Event ID 90661
510(K)NumberK030719 
Product Classification Device, analysis, anterior segment - Product Code MXK
ProductPentacam HR REF 70900. Used to image the anterior segment of the eye.
Code Information Software version: 1.26r26 and 1.26r27 Model Number: 70900 UDI-DI Code: 04049584000026 Serial Numbers: 70900 0574 8160 70900 0925 0240 70900 0995 2250 70900 1664 8130 70900 1995 2250 70900 3451 7060 70900 3795 2250 70900 3965 1270 70900 4041 7010 70900 4172 2110 70900 4795 2250 70900 6234 7150 70900 7552 1160 70900 7952 1180 70900 8804 6140 70900 8813 3140 70900 9142 0121 70900 9695 2250 70900 9795 2250
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 Commerce19 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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