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FDA · Medical device recall

ValueLine Mat Platform Model C2230A,B,C… and 4 more products

July 12, 2006

Date posted by the FDA
July 12, 2006
Status
Terminated
Filed by
Sammons Preston Rolyan
Reason
There have been reports of structural failure on the skirt of select tables. The risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced.
Distribution pattern
Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.

5 products in this recall

ValueLine Mat Platform Model C2230A,B,C…

Product
ValueLine Mat Platform Model C2230A,B,C; C922-30A, B,and C; C6904, C6903, C6902, C6901. All tables have the standard platform and the model numbers represent the additional shelves or drawers and the arrangement.
Quantity
561 devices total
Codes and lots
Serial number prefixess 2509 throuth 2511.
Recall started
Jan. 25, 2006
Device type
Plinth
Root cause (FDA)
Other
What the company told customers
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
Recall number
Z-1207-06

Midland Deluxe Mat Platform- Model C2237A…

Product
Midland Deluxe Mat Platform- Model C2237A, B and C
Quantity
8 devices total
Codes and lots
Serial number prefixess 2509 throuth 2511
Recall started
Jan. 25, 2006
Device type
Plinth
Root cause (FDA)
Other
What the company told customers
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
Recall number
Z-1208-06

Midland Deluxe Mat Platform with Adjustable Backrest Model C5522-30A…

Product
Midland Deluxe Mat Platform with Adjustable Backrest Model C5522-30A, B, and C,
Quantity
831 devices total
Codes and lots
Serial number prefixess 2509 throuth 2511
Recall started
Jan. 25, 2006
Device type
Plinth
Root cause (FDA)
Other
What the company told customers
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
Recall number
Z-1209-06

Midland Space-Saver Mat Platform Model C2236

Product
Midland Space-Saver Mat Platform Model C2236
Quantity
74 devices total
Codes and lots
Serial number prefixess 2509 throuth 2511
Recall started
Jan. 25, 2006
Device type
Plinth
Root cause (FDA)
Other
What the company told customers
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
Recall number
Z-1210-06

ValueLine Space-Saver Folding Mat Platform model C9222-30S…

Product
ValueLine Space-Saver Folding Mat Platform model C9222-30S; C2230S
Quantity
23 devices total
Codes and lots
Serial number prefixess 2509 throuth 2511
Recall started
Jan. 25, 2006
Device type
Plinth
Root cause (FDA)
Other
What the company told customers
Letters were sent to customers certified mail on 1/25-26/2006 instructing them to take the tables out of service until it could be inspected by a sales representative. Sales represenatives are following up with customers in person to inspect tables.
Recall number
Z-1211-06

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1207-06, Z-1208-06, Z-1209-06, Z-1210-06, Z-1211-06. The agency record governs; check it and the company before acting.

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