| Date Initiated by Firm |
May 11, 2021 |
| Date Posted |
June 15, 2021 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1861-2021 |
| Recall Event ID |
87939 |
| Product Classification |
Table, operating-room, ac-powered - Product Code FQO
|
| Product |
Skyton Bracket Flatscreen, Revision 2 & 3-The FS32 is a single monitor mounting bracket intended for use with a 32 inch (maximum) flat screen monitor.
Model: FS32
|
| Code Information |
Serial Numbers:
1504-314-00-1-0002 up to 2006-314-00-1-0185
***UPDATED 12/10/21***
Recall expanded to include Rev 3. Complete list of recalled Serial Numbers:
1504-314-00-1-0002
1504-314-00-1-0003
1504-314-00-1-0004
1508-314-00-1-0005
1508-314-00-1-0006
1508-314-00-1-0007
1508-314-00-1-0008
1509-314-00-1-0009
1509-314-00-1-0010
1509-314-00-1-0011
1509-314-00-1-0012
1510-314-00-1-0013
1510-314-00-1-0014
1601-314-00-1-0016
1601-314-00-1-0017
1610-314-00-1-0018
1610-314-00-1-0019
1610-314-00-1-0020
1610-314-00-1-0021
1610-314-00-1-0022
1610-314-00-1-0023
1610-314-00-1-0024
1610-314-00-1-0025
1610-314-00-1-0026
1610-314-00-1-0027
1610-314-00-1-0028
1610-314-00-1-0029
1610-314-00-1-0030
1610-314-00-1-0031
1610-314-00-1-0032
1802-314-00-1-0033
1802-314-00-1-0034
1802-314-00-1-0035
1802-314-00-1-0036
1802-314-00-1-0037
1802-314-00-1-0038
1802-314-00-1-0039
1802-314-00-1-0040
1802-314-00-1-0041
1802-314-00-1-0042
1803-314-00-1-0043
1803-314-00-1-0044
1803-314-00-1-0045
1803-314-00-1-0046
1803-314-00-1-0047
1803-314-00-1-0048
1803-314-00-1-0049
1803-314-00-1-0050
1803-314-00-1-0051
1803-314-00-1-0052
1809-314-00-1-0053
1809-314-00-1-0054
1809-314-00-1-0055
1809-314-00-1-0056
1809-314-00-1-0057
1809-314-00-1-0058
1809-314-00-1-0059
1809-314-00-1-0060
1809-314-00-1-0061
1809-314-00-1-0062
1809-314-00-1-0063
1809-314-00-1-0064
1810-314-00-1-0065
1810-314-00-1-0066
1810-314-00-1-0067
1810-314-00-1-0068
1810-314-00-1-0069
1810-314-00-1-0070
1811-314-00-1-0071
1811-314-00-1-0072
1811-314-00-1-0073
1811-314-00-1-0074
1811-314-00-1-0075
1811-314-00-1-0076
1811-314-00-1-0077
1811-314-00-1-0078
1811-314-00-1-0079
1811-314-00-1-0080
1811-314-00-1-0083
1811-314-00-1-0084
1811-314-00-1-0085
1811-314-00-1-0087
1811-314-00-1-0088
1811-314-00-1-0089
1811-314-00-1-0090
1901-314-00-1-0091
1901-314-00-1-0092
1901-314-00-1-0093
1901-314-00-1-0094
1901-314-00-1-0095
1901-314-00-1-0096
1901-314-00-1-0097
1901-314-00-1-0098
1901-314-00-1-0099
1901-314-00-1-0100
1901-314-00-1-0101
1901-314-00-1-0102
1901-314-00-1-0103
1901-314-00-1-0104
1901-314-00-1-0105
1901-314-00-1-0106
1901-314-00-1-0107
1901-314-00-1-0108
1901-314-00-1-0109
1904-314-00-1-0121
1904-314-00-1-0127
2005-314-00-1-0131
2005-314-00-1-0132
2005-314-00-1-0133
2005-314-00-1-0134
2005-314-00-1-0135
2005-314-00-1-0136
2005-314-00-1-0137
2005-314-00-1-0138
2005-314-00-1-0139
2005-314-00-1-0140
2005-314-00-1-0141
2005-314-00-1-0142
2006-314-00-1-0143
2006-314-00-1-0144
2006-314-00-1-0145
2006-314-00-1-0146
2011-314-00-2-0002
2011-314-00-2-0003
2011-314-00-2-0004
2011-314-00-2-0005
2011-314-00-2-0006
2011-314-00-2-0007
2011-314-00-2-0008
2011-314-00-2-0009
2011-314-00-2-0010
2011-314-00-2-0011
2011-314-00-2-0012
2011-314-00-2-0013
2011-314-00-2-0014
2011-314-00-2-0015
2011-314-00-2-0016
2011-314-00-2-0017
2011-314-00-2-0018
2011-314-00-2-0019
2011-314-00-2-0020
2011-314-00-2-0021
2011-314-00-2-0022
2011-314-00-2-0023
2011-314-00-2-0024
2011-314-00-2-0025
2011-314-00-2-0026
2011-314-00-2-0027
2011-314-00-2-0028
2011-314-00-2-0029
2011-314-00-2-0030
2011-314-00-2-0031
2011-314-00-2-0032
2011-314-00-2-0033
2011-314-00-2-0034
2011-314-00-2-0035
2011-314-00-2-0036
2011-314-00-2-0037
2011-314-00-2-0038
2011-314-00-2-0039
2011-314-00-2-0040
2011-314-00-2-0041
2011-314-00-2-0042
2011-314-00-2-0043
2011-314-00-2-0044
2011-314-00-2-0045
2011-314-00-2-0046
2011-314-00-2-0047
2011-314-00-2-0048
2011-314-00-2-0049
2011-314-00-2-0050
2011-314-00-2-0051
2011-314-00-2-0052
2011-314-00-2-0053
2011-314-00-2-0054
2011-314-00-2-0055
2011-314-00-2-0056
2011-314-00-2-0057
2011-314-00-2-0058
2011-314-00-2-0059
2011-314-00-2-0060
2011-314-00-2-0061
2011-314-00-2-0062
2011-314-00-2-0063
2011-314-00-2-0064
2011-314-00-2-0065
2011-314-00-2-0066
2011-314-00-2-0067
2011-314-00-2-0068
2011-314-00-2-0069
2011-314-00-2-0070
2011-314-00-2-0071
2011-314-00-2-0072
2011-314-00-2-0073
2011-314-00-2-0074
2011-314-00-2-0075
2011-314-00-2-0076
2011-314-00-2-0077
2011-314-00-2-0078
2011-314-00-2-0079
2011-314-00-2-0080
2011-314-00-2-0081
2011-314-00-2-0082
2011-314-00-2-0083
2011-314-00-2-0084
2011-314-00-2-0085
2011-314-00-2-0086
2011-314-00-2-0087
2011-314-00-2-0088
2011-314-00-2-0089
2011-314-00-2-0090
2011-314-00-2-0091
2011-314-00-2-0092
2011-314-00-2-0093
2011-314-00-2-0094
2011-314-00-2-0095
2011-314-00-2-0096
2011-314-00-2-0097
2011-314-00-2-0098
2011-314-00-2-0099
2011-314-00-2-0100
2011-314-00-2-0101
2011-314-00-2-0102
2011-314-00-2-0103
2011-314-00-2-0104
2011-314-00-2-0105
2011-314-00-2-0106
2011-314-00-2-0107
2011-314-00-2-0108
2011-314-00-2-0109
2011-314-00-2-0110
2011-314-00-2-0111
2011-314-00-2-0112
2011-314-00-2-0113
2011-314-00-2-0114
2011-314-00-2-0115
2011-314-00-2-0116
2011-314-00-2-0117
2011-314-00-2-0118
2011-314-00-2-0119
2011-314-00-2-0120
2011-314-00-2-0121
2011-314-00-2-0122
2011-314-00-2-0123
2011-314-00-2-0124
2011-314-00-2-0125
2011-314-00-2-0126
2011-314-00-2-0127
2011-314-00-2-0128
2011-314-00-2-0129
2011-314-00-2-0130
2011-314-00-2-0131
2011-314-00-2-0132
2011-314-00-2-0133
2011-314-00-2-0134
2011-314-00-2-0135
2011-314-00-2-0136
2011-314-00-2-0137
2011-314-00-2-0138
2011-314-00-2-0139
2011-314-00-2-0140
2011-314-00-2-0141
2011-314-00-2-0142
2011-314-00-2-0143
2011-314-00-2-0144
2011-314-00-2-0145
2011-314-00-2-0146
2011-314-00-2-0147
2011-314-00-2-0148
2011-314-00-2-0149
2011-314-00-2-0150
2011-314-00-2-0151
2011-314-00-2-0152
2011-314-00-2-0153
2011-314-00-2-0154
2011-314-00-2-0155
2011-314-00-2-0156
2011-314-00-2-0157
2011-314-00-2-0158
2011-314-00-2-0160
2011-314-00-2-0161
2011-314-00-2-0162
2011-314-00-2-0163
2011-314-00-2-0165
2103-314-00-2-0170
|
Recalling Firm/
Manufacturer |
Skytron, Div. The KMW Group, Inc
5085 Corporate Exchange Blvd SE
Grand Rapids MI 49512-5515
|
| For Additional Information Contact |
SAME
616-656-2900
|
Manufacturer Reason
for Recall |
Failure of the FS32 Monitor Brackets from the mounting block could potentially loosen over time and eventually detach from the baseplate, result in the display interface dismounting from its attachment point, causing injury to patients or staff
|
FDA Determined
Cause 2 |
Device Design |
| Action |
Skytron issued Urgent Medical Device Correction notice on 5/11/21. Letter states reason for recall, health risk and action to take:
Identify your FS32 monitor bracket(s). Serial numbers can be found on the UDI label located on the back of the bracket.
Inspect your FS32 monitor bracket(s) per the instructions on the final page of this document. Remove from service any bracket where evidence is identified that the device may fail.
Skytron authorized representatives have been directed to contact you and schedule a service visit. Please contact Erin Woolf, at 616-656-2998 or ewoolf@skytron.us with any questions.
***UPDATED 12/10/21***
On November 22, 2021, the firm sent updated letters due to an expansion of the recall scope. Revision 3 models of the FS32 Monitor Bracket were added to the recall.
Customer instructions remain the same. |
| Quantity in Commerce |
278 units US; 7 units OUS |
| Distribution |
Worldwide distribution - US Nationwide and the countries of Australia, Japan. |
| 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.
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