| | Class 2 Device Recall Philips |  |
| Date Initiated by Firm | May 01, 2021 |
|---|
| Create Date | June 30, 2021 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1983-2021 |
|---|
| Recall Event ID |
87974 |
| 510(K)Number | K033357 |
|---|
| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems.
BB (Big Bore) Oncology, BB (Big Bore) Radiology:
728242/728243/728244/728272 - Brilliance Big Bore |
|---|
| Code Information |
Model/ Serial Number/UDI: N/A 728242 20004 N/A 728242 768007 (01)00884838095168 728242 20013 N/A 728243 75107 N/A 728243 7729 N/A 728243 7786 N/A 728243 7741 N/A 728243 7820 N/A 728243 7892 N/A 728243 75027 N/A 728243 75029 N/A 728243 7941 N/A 728243 75047 N/A 728243 7467 N/A 728243 7831 N/A 728243 7831 N/A 728243 7560 N/A 728243 75067 N/A 728243 7689 N/A 728243 7442 N/A 728243 75111 N/A 728243 7927 N/A 728243 7558 N/A 728243 7769 N/A 728243 7284 N/A 728243 75066 N/A 728243 7905 N/A 728243 7800 N/A 728243 7724 N/A 728243 7946 N/A 728243 7385 N/A 728243 7192 N/A 728243 7211 N/A 728243 7891 N/A 728243 75041 N/A 728243 7269 N/A 728243 7064 N/A 728243 7116 N/A 728243 7214 N/A 728243 7795 N/A 728243 7701 N/A 728243 7810 N/A 728243 7743 N/A 728243 75064 N/A 728243 75120 N/A 728243 750005 N/A 728243 750013 N/A 728244 760014 (01)00884838059450(21)760014 728244 760013 (01)00884838059450(21)760013 728244 76230 N/A 728244 76259 (01)00884838059450(21)76259 728244 76238 (01)00884838059450(21)76238 728244 76147 (01)00884838059450(21)76147 728244 76178 (01)00884838059450(21)76178 728244 7764 N/A 728244 760045 (01)00884838059450(21)760045 728244 760023 (01)00884838059450(21)760023 728244 75123 N/A 728244 760047 (01)00884838059450(21)760047 728244 76109 (01)00884838059450(21)76109 728244 760056 (01)00884838059450(21)760056 728244 7653 N/A 728244 76249 (01)00884838059450(21)76249 728244 76228 (01)00884838059450(21)76228 728244 76299 (01)00884838059450(21)76299 728244 7926 N/A 728244 7533 N/A 728244 7917 N/A 728244 76095 (01)00884838059450(21)76095 728244 7874 N/A 728244 7452 N/A 728244 76113 (01)00884838059450(21)76113 728244 76140 (01)00884838059450(21)76140 728244 76078 (01)00884838059450(21)76078 728244 7781 N/A 728244 76079 (01)00884838059450(21)76079 728244 760015 (01)00884838059450(21)760015 728244 760029 N/A 728244 760011 (01)00884838059450(21)760011 728244 7694 N/A 728244 76248 N/A 728244 7747 N/A 728244 7773 (01)00884838059450(21)7773 728244 7826 N/A 728244 76290 (01)00884838059450(21)76290 728244 7915 N/A 728244 7721 N/A 728244 76268 (01)00884838059450(21)76268 728244 76177 (01)00884838059450(21)76177 728244 760003 (01)00884838059450(21)760003 728244 760004 (01)00884838059450(21)760004 728244 76214 (01)00884838059450(21)76214 728244 76250 (01)00884838059450(21)76250 |
Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
Manufacturer Reason
for Recall | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the
cables resulting in patient, operator, bystander, or service person to serious injury. |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | Philips issued URGENT- Field Safety Notice Medical Device Correction letter on 5/1/21 FSN 72800751 and FSN 88200530 . Letter states reason for recall, health risk and action to take: " Be aware of this hazard when the safety clip is missing from the joint assembly between the Monitor Bracket Assembly and the Ceiling Suspension Arm.
" Inspect the joint area of their CCT DVI Ceiling Mount Arm (the circled area in picture at theright) and observe that the safety clip is installed (as depicted in pictures below).
" When this hazard occurs, the monitor may become difficult to rotate relative to the Suspension Arm.
When these symptoms are recognized, in order to avoid the occurrence of a hazardous situation, take the following actions:
stop using the suspension monitor clinically
move the monitor arm away from any person
call Philips Service for repairs.
Please acknowledge the receipt of this notice by completing, signing, and returning the form attached at the end of this communication to the indicated email address.
Philips will inspect systems via Field Change Order FCO 88200530. Systems failing the inspection will be corrected via Field Change Order FCO 882531
For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts). |
|---|
| Quantity in Commerce | 1,301 Monitor Bracket Assemblies total |
|---|
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Mexico, AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CO, CU, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GE, GI, GL, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KG, KH, KR, LA, LB, LK, LT, LY, MM, MN, MU, MV, MY, NI, NL, NO, NZ, OM, PA, PF, PH, PK, PL, PS, PT, QA, RE, RU, RW, SA, SE, SG , SI, SK, TH, TN, TR, UZ, VN, XK, YE, ZA, ZW. |
|---|
| 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 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) Database | 510(K)s with Product Code = JAK
|
|---|
|
|
|
