U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Inaccuracies in svo2, temperature, ph, pco2, po2, hematocrit, and potassium readings following a software upgrade to version 1.69.
Acción
A voluntary Urgent Medical Device Correction notice that clearly explains initial in-vivo calibration requirements, device operating ranges, and temperature measurements was sent on 08/17/2015, via express mail to consignees of CDI System 500 v1.69. Following the initial notice, Terumo will be updating the Operators Manual and will send the new manual to each consignee when available. One manual per unit at each facility will be provided. Customers with questions and return response forms may contact:
Terumo Recall Email: tcvs.recall@terumomedical.com
Terumo Recall Fax: 734-741-6149
Terumo CVS Customer Service: 1.800.521.2818, Monday - Friday, 8 a.m. 6 p.m. ET.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
Some of p/n 14-521614b lot 375440 was mislabeled as p/n 14-521614 lot 375440.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall Notice dated August 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by customer. Customers were instructed to immediately locate and discontinue use of the affected product.
This action requires the immediate location and discontinued use of the item
and its immediate return to Zimmer Biomet Spine. Specifically, customers were REQUIRED to take the following steps:
" Immediately locate and remove from circulation the items consigned/loaned to your
account as identified on page two of this notice.
" Carefully follow the instructions on the enclosed "Response Form".
" If you have further distributed these items to medical facilities, you MUST notify them of this action. This letter MUST be given to the person responsible for receiving recall notices. However, you are charged with the location and return of these items.
Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone:
Online:
Fax:
Phone:
Regular Mail:
www. fda .gov /MedWatch/report.htm
(800) FDA-0178
(800} FDA-1088
Use postage-paid FDA form 3500 available at www.fda.gov/Medwatch/getforms.htm
and mail to Medwatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
Questions related to this notice should be directed to 303-501-8400 Monday through Friday, 8 a.m.to 5 p.m. MST.
Zimmer Blomet
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Alcon is initiating a voluntary recall of all lx3 microscope floor stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure.
Acción
Alcon sent an Urgent Medical Device Correction letter dated August 11, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Alcon at 800-862-5266.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Saline, vascular access flush - Product Code NGT
Causa
Sterility may be compromised.
Acción
Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Saline, vascular access flush - Product Code NGT
Causa
Sterility may be compromised.
Acción
Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Saline, vascular access flush - Product Code NGT
Causa
Sterility may be compromised.
Acción
Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Saline, vascular access flush - Product Code NGT
Causa
Sterility may be compromised.
Acción
Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Warmer, irrigation solution - Product Code LHC
Causa
The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. if channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.
Acción
Consignees were sent on 8/18/2015 an Ecolab "Urgent Medical Device Recall" letter dated August 18, 2015. The letter was addressed to Recall Coordinator or Risk Manager. The letter described the problem and the product involved in the recall. Advised consignees to quarantine all affected lots, and notify their customers of the recall which is to be carried out to users level. Requested consignees to complete and return the enclosed Recall Response Form. For questions they can contact Customer Service at 1-800-824-3027 or e-mail customerservice@microtekmed.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
It has been discovered that due to lack of information accompanying documents the product fails to comply with 21cfr 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
Acción
Villa Radiology Systems Planned Action:
1. The current users manuals have been updated and addendums to the user manuals have been developed for currently installed Rotograph Evo
3D and Imax Touch 3D. The revisions and addendums contain all information required under 21 CFR 1020.33(c), 1020.33(d), 1020.33(g), and
1020.33(j).
2. New Rotograph Evo 3D and Imax Touch 3D systems will ship with the updated user manual.
3. Addendums will be provided to all end users
CDRH approves the CAP subject to the following conditions:
1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
It has been discovered that due to lack of information accompanying documents the product fails to comply with 21cfr 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
Acción
Villa Radiology Systems Planned Action:
1. The current users manuals have been updated and addendums to the user manuals have been developed for currently installed Rotograph Evo
3D and Imax Touch 3D. The revisions and addendums contain all information required under 21 CFR 1020.33(c), 1020.33(d), 1020.33(g), and
1020.33(j).
2. New Rotograph Evo 3D and Imax Touch 3D systems will ship with the updated user manual.
3. Addendums will be provided to all end users
CDRH approves the CAP subject to the following conditions:
1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Images from the centricity pacs-iw with universal viewer and
centricity universal viewer may be missing when a system parameter maproute is set to a value greater than 1.
Acción
The firm sent out an Urgent Medical Device Correction letter dated 8/11/2015 to all affected customers. Letter states that No User activity required. GE Healthcare has completed a remote inspection of your system and found that this system parameter is currently set to the default setting of 1. The firm will correct all affected systems by a providing software update.
The letter also states that if the customer has any questions they should call GE Healthcare Service at 1-800-437-1171 or their local service representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Images from the centricity pacs-iw with universal viewer and
centricity universal viewer may be missing when a system parameter maproute is set to a value greater than 1.
Acción
The firm sent out an Urgent Medical Device Correction letter dated 8/11/2015 to all affected customers. Letter states that No User activity required. GE Healthcare has completed a remote inspection of your system and found that this system parameter is currently set to the default setting of 1. The firm will correct all affected systems by a providing software update.
The letter also states that if the customer has any questions they should call GE Healthcare Service at 1-800-437-1171 or their local service representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
In certain circumstances involving select da vinci si single-site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Acción
Intuitive Surgical sent an Urgent Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following:
1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures.
2. Replace any instrument that shows signs of damage and contact Intuitive Surgical
Customer Service.
3. Complete and return the attached Acknowledgment Form to Intuitive Surgical using
the instructions provided.
4. Please retain a copy of this notice as well as the attached instructions with your Single-Site User Manual.
If you need further information or support concerning this issue, please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below:
¿ North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail:
customersupport-servicesupport@intusurg.com
¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6
PM CET) or ics@intusurg.com
¿ South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ)
¿ Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST)
For questions regarding this recall call 408-523-2100.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Plate, fixation, bone - Product Code HRS
Causa
The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. the thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws.
Acción
Trilliant Surgical sent an Urgent Medical Device Recall letter dated August 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The letter instructed and confirmed consignees to discontinue use of the affected lots, quarantine, and return product (if not yet done so) in accordance with an included acknowledgement sheet. For further questions, please call 1(800) 495-2919 , 8:00am - 5:00pm CST
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The medtronic cover light handle disposable gloves, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
Acción
Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees.
Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes.
Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution.
AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well.
Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read:
RECALL NOTICE
Medtronic announced the recall l of Devon Light Glove contained in this kit
after it was sealed and sterilized. All other components in the kit are not
affected by this recall.
1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside
2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution.
Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875.
For any questions about this recall, please call 321-527-7714.
For questions regarding this recall call 404-259-6387.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The expiration date was incorrectly printed on the pouch/box labels of 19 products that were shipped to customer sites. the manufacturing date was accidentally used (copied) for the expiration date.
Acción
The firm, Abbott Electrophysiology, sent an "URGENT PRODUCT RECALL" letter dated August 11, 2015. A customer recall notification letter was distributed to firm representatives who will visit each consignee and inspect inventory for affected product. Letters were provided to reps on August 12, 2015. The letter describes the product, problem and actions to be taken. The customers were informed that the product they have in stock will be return to the firm and will be provided a replacement product free of charge.
If you have any questions, contact Quality Director at 650-681-1744.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Acción
Lima Corporate sent an Urgent Attention Recall letter on August 11, 2015, to US distributors and Sales Agents. The affected customers were instructed to examine their inventory, return the affected lots to the recalling firm, and complete a response form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Acción
Lima Corporate sent an Urgent Attention Recall letter on August 11, 2015, to US distributors and Sales Agents. The affected customers were instructed to examine their inventory, return the affected lots to the recalling firm, and complete a response form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
In certain circumstances involving select da vinci si single-site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Acción
Intuitive Surgical sent an Urgent Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following:
1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures.
2. Replace any instrument that shows signs of damage and contact Intuitive Surgical
Customer Service.
3. Complete and return the attached Acknowledgment Form to Intuitive Surgical using
the instructions provided.
4. Please retain a copy of this notice as well as the attached instructions with your Single-Site User Manual.
If you need further information or support concerning this issue, please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below:
¿ North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail:
customersupport-servicesupport@intusurg.com
¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6
PM CET) or ics@intusurg.com
¿ South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ)
¿ Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST)
For questions regarding this recall call 408-523-2100.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Screw, fixation, bone - Product Code HWC
Causa
Dls pin breakage during planned implant removal, after uneventful and successful healing of the fracture. this notice to additional consignees identified after recall z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head.
Acción
Synthes sent an Urgent Notices of Medical Device Recall letter, dated August 11, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to return affected devices and response forms.
For further questions please call (610) 719-6500.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Accelerator, linear, medical - Product Code IYE
Causa
This update is intended to provide a software update for the syngo rt oncologist, which is currently running sw version 4.2 or 4.3. the safety-related issues, which were described in the customer safety notice distributed as ufsn-rtt/rto 4.3 adaptive targeting [auto-registration]. the update contains several important safety and performance fixes.
Acción
The firm, Siemens, sent Recall letters, dated August 2015, that describe the product, the problem, and correction, will be hand-delivered to affected sites at the time the fix is implemented by a Siemens technician.
If you have any questions, contact Regulatory Technical Specialist at 610-448-6471 or email: marlynne.galloway@siemens.com
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Stretcher, wheeled - Product Code FPO
Causa
Hole elongation in the telescoping load frame channel. a hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame.
Acción
Ferno began calling their customers on 8/3/2015. The firm informed their customers of the following:
To provide optimal Customer Experience and minimal disruption to your service, the iNX field action involves the following steps:
" Exchange of your current iNX with a new iNX;
" Participation in a brief training session; and
" Inspection of your Ferno Model 175 antler and rail fastening system as
requested by the Dept. of Transportation.
As you await delivery of your new iNX, it is important you ensure proper function of the fastening system and iNX telescoping load frame.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Some devices exhibit backup vvi operation due to a backup reset.
Acción
The notification material is in the form of a Physician Letter was delivered to physicians by FedEx overnight service. The mailing went out on August 17, 2015 for receipt on August 18, 2015.
The firm's notification letter identifies clinical implications.
Clinical Implications
In the event that an Ellipse, Fortify Assura, Unify Assura, or Quadra Assura ICD enters the back-up safety mode, the nominal operational settings will be VVI pacing mode, 67 ppm, 5.0v/0.6ms with bipolar pacing output and defibrillation settings of aVF detection rate of 146 bpm and 36J high voltage therapy. In the event an Assurity or Allure pacemaker enters backup mode, it will have output settings of VVI pacing mode, 67 ppm, 5.0v/0.6ms with unipolar pacing.
This anomaly can only occur when the patient is being actively monitored by a Merlin@home bedside transmitter. If a device enters backup mode, the ICD will deliver a patient vibratory alert and the pacemaker will deliver a patient audible alert. If backup operation is encountered, St. Jude Medical Technical Services (1-800-722-3774) can assist with non-invasively restoring the device to normal operation.
The firm's notification also idenfities recommendations and mitigations.
Recommendations and Mitigations
Once available, a Merlin@home transmitter software update will be performed automatically over its telephone, broadband or cellular connection without requiring any action from you or your patients. No changes to the patients remote or in-clinic follow up schedules are required. In the event a patients device reverts to back-up mode, the firm recommends bringing the patient back in the clinic to clear the condition and return the device to full functionality.
If you have any questions or concerns contact the local St. Jude Medical representative or St. Jude Medical's Technical Services Department.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Disposable reflective marker spheres (drms) for brainlab image guided surgery (igs) systems: drms spheres may separate at the mid-point where the two halves of the sphere are sealed together.
Acción
The firm, Brainlab AG, sent out a" FIELD SAFETY NOTICE/ PRODUCT NOTIFICATION" dated 7/23/2015 to its customers. The firm sent this letter to mitigate the potential effects of the affected Disposable Reflective Marker Spheres (DRMS) when used with Brainlab Image Guided Surgery (IGS) systems. The firm advised the medical users that they should take the following steps prior to each procedure using Brainlab DRMS spheres for Brainlab IGS systems:
-Prior to opening the package containing the spheres, visually inspect the spheres in the blister pack for any signs of separation between the two halves of the sphere. If there is any indication that the spheres may have separated, use a different blister pack for the procedure and repeat this step with the new pack. Discard any and all affected spheres and inform your Brainlab support representative about the occurrence of the issue. If there is no visual sign of sphere separation, proceed to the next step.
-Prior to the start of the procedure, screw each DRMS sphere onto the tool and tighten. Upon tightening, inspect again to determine whether any separation between the two halves is evident. If separation is evident, remove and discard the affected sphere. Replace your surgical gloves, then replace the separated sphere with a new sphere, inspecting it as above. If no separation is evident, proceed with the clinical procedure.
-Be sure to discard and replace your surgical gloves any time that a sphere with evident separation is found upon affixing the sphere to the tool, and every time after a separated sphere was touched.
-Caution: Do not affix the sphere to the tool over the surgical area to minimize the risk of a sphere, or any portion thereof, falling onto the patient or into the surgical wound. Also avoid affixing the sphere over other sterile areas (such as surgical trays) to minimize potential contamination in case of sphere separation.
-Reminder: In general, do not use defective or deformed marker
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
In certain circumstances involving select da vinci si single-site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Acción
Intuitive Surgical sent an Urgent Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following:
1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures.
2. Replace any instrument that shows signs of damage and contact Intuitive Surgical
Customer Service.
3. Complete and return the attached Acknowledgment Form to Intuitive Surgical using
the instructions provided.
4. Please retain a copy of this notice as well as the attached instructions with your Single-Site User Manual.
If you need further information or support concerning this issue, please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below:
¿ North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail:
customersupport-servicesupport@intusurg.com
¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6
PM CET) or ics@intusurg.com
¿ South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ)
¿ Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST)
For questions regarding this recall call 408-523-2100.