Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Plex Elite 9000 Swept Source Optical Coherence Tomography System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Plex Elite 9000 Swept Source Optical Coherence Tomography System see related information
Date Initiated by Firm October 16, 2018
Create Date January 02, 2020
Recall Status1 Terminated 3 on June 11, 2021
Recall Number Z-0770-2020
Recall Event ID 83229
510(K)Number K161194  
Product Classification Tomography, optical coherence - Product Code OBO
Product The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
Code Information OBO /HJO  Serial Numbers: PE9000-001, PE9000-002, PE9000-003, PE9000-003,PE9000-004, PE9000-005, PE9000-006, PE9000-007, PE9000-008, PE9000-009, PE9000-0010, PE9000-0011, PE9000-0012, PE9000-0013, PE9000-0014, PE9000-0015, PE9000-0016, PE9000-0020, PE9000-0021, PE9000-0022, PE9000-0023, PE9000-0024, PE9000-0025, PE9000-0026, PE9000-0027, PE9000-0029, PE9000-0030, PE9000-0031, PE9000-0032, PE9000-0033, PE9000-0034, PE9000-0035, PE9000-0036, PE9000-0038, PE9000-0039, PE9000-0040, PE9000-0041, PE9000-0042, PE9000-0043, PE9000-0044, PE9000-0045, PE9000-0046, PE9000-0047, PE9000-0048, PE9000-0049, PE9000-0050, PE9000-0051, PE9000-0052, PE9000-0053, PE9000-0054, PE9000-0055, PE9000-0056, PE9000-0057, PE9000-0058, PE9000-0059, PE9000-0060, PE9000-0061, PE9000-0062, PE9000-0063, PE9000-0064, PE9000-0065, PE9000-0066, PE9000-0067, PE9000-0068, PE9000-0069, PE9000-0070, PE9000-0071, PE9000-0072, PE9000-0073, PE9000-0074, PE9000-0075, PE9000-0076, PE9000-0077, PE9000-0078, PE9000-0079, PE9000-0080, PE9000-0081, PE9000-0082, PE9000-0083, PE9000-0084, PE9000-0085, PE9000-0086, PE9000-0087, PE9000-0088, PE9000-0089, PE9000-0090, PE9000-0091, PE9000-0092, PE9000-0093, PE9000-0094, PE9000-0095, PE9000-0096, PE9000-0097, PE9000-0098, PE9000-0099, PE9000-0100,  PE9000-0101, PE9000-0102, PE9000-0103, PE9000-0104, PE9000-0105, PE9000-0106, PE9000-0107, PE9000-0108, PE9000-0109, PE9000-0110, PE9000-0111, PE9000-0112, PE9000-0113, PE9000-0114, PE9000-0115, PE9000-0116, PE9000-0117, PE9000-0118, PE9000-0119, PE9000-0120, PE9000-0121, PE9000-0122, PE9000-0123, PE9000-0124, PE9000-0125, PE9000-0126, PE9000-0127, PE9000-0128, PE9000-0129, PE9000-0130, PE9000-0131, PE9000-0132, PE9000-0133, PE9000-0134, PE9000-0135, PE9000-0137, PE9000-0138, PE9000-0139, PE9000-0140, PE9000-0141, PE9000-0142, PE9000-0143, PE9000-0144, PE9000-0145, PE9000-0146, PE9000-0147, PE9000-0148, PE9000-0149, PE9000-0150, PE9000-0151, PE9000-0152, PE9000-0153, PE9000-0154, PE9000-0155, PE9000-0156, PE9000-0158 
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec, Inc.
5160 Hacienda Dr
Dublin CA 94568-7562
For Additional Information Contact Allen Jones
925-557-4100
Manufacturer Reason
for Recall		 Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch.
FDA Determined
Cause 2		 Device Design
Action Recalling Firm issued Urgent Medical Device Recall notices to all customers dated October 16, 2018. Customers were advised to take the following actions: Until the mandatory hardware update has been performed, follow the procedure below to continue the use of the PLEX Elite 9000: When adjusting the height of the Power Table, touch only the black plastic portion of the Up/Down switch. Avoid any contact with the entire metal enclosure (including mounting screws) surrounding the black plastic Up/Down switch. Failure to follow this procedure may result in potential injury. CAUTION: Operator(s) with an electrical implant are more sensitive to electrostatic discharge and must avoid use of the system prior to the hardware update. To correct the issue, customers will be contacted by a representative to schedule a Field Service Engineer to perform a mandatory hardware update for their PLEX Elite 9000.
Quantity in Commerce 151 devices
Distribution Worldwide distribution - US Nationwide distribution in the states of CA, TX, NY, MA, OH, PA, IA, , KY, FL, MI, IL, MD and Germany, Japan, Switzerland, France Italy, Australia, Austria, Korea, China, India, Canada, Singapore, Norway, Taiwan, Israel, UAE.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OBO and Original Applicant = CARL ZEISS MEDITEC, INC.
-
-