Medical Device
Manufacturing
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Z-1273-2021Class II

Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of...

Philips Healthcare (Suzhou) Co., Ltd. / initiated 2021-02-24 / Terminated / root cause: manufacturing process

Philips Healthcare (Suzhou) Co., Ltd. began a recall of Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product... on . FDA classified it as Class II and gives the reason as "Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1273-2021
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips Healthcare (Suzhou) Co., Ltd.
Product
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
Product code
JAK System, X-Ray, Tomography, Computed
Reason for recall
Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
On 2/18/2021, Philips issued an Urgent Medical Device Correction because the firm has detected an issue with some actuators used in the couch of Incisive CT and Access CT systems, which could result in the couch unexpectedly moving slowly downward to its limit position.
Quantity in commerce
109 systems
Distribution
Worldwide distribution - US Nationwide distribution in the states of KY, FL, St. Croix, and the countries of Australia, Bolivia, China, Germany, Hungary, Italy, Japan, Republic of Korea, Latvia, Palestine, Puerto Rico, Romania, Russia, Saudi Arabia, Senegal, Serbia, Spain, Sweden, Thailand, Uzbekistan.
Product codes and lots
Unique Device Identifier (01)00884838059849(21)304034  (01)00884838059849(21)325078  (01)00884838085015(21)500218  (01)00884838085015(21)500219  (01)00884838085015(21)500221  (01)00884838085015(21)500222  (01)00884838085015(21)500223  (01)00884838085015(21)500224  (01)00884838085015(21)500225  (01)00884838085015(21)500226  (01)00884838085015(21)500227  (01)00884838085015(21)500229  (01)00884838085015(21)500231  (01)00884838085015(21)500233  (01)00884838085015(21)500234  (01)00884838085015(21)500237  (01)00884838085015(21)500238  (01)00884838085015(21)500239  (01)00884838085015(21)500241  (01)00884838085015(21)500242  (01)00884838085015(21)500245  (01)00884838085015(21)500247  (01)00884838085015(21)500248  (01)00884838085015(21)500249  (01)00884838085015(21)500251  (01)00884838085015(21)500252  (01)00884838085015(21)500254  (01)00884838085015(21)500255  (01)00884838085015(21)500256  (01)00884838085015(21)500257  (01)00884838085015(21)500258  (01)00884838085015(21)500261  (01)00884838085015(21)500264  (01)00884838085015(21)500274  (01)00884838085015(21)500283  (01)00884838085015(21)500296  (01)00884838085015(21)530038  (01)00884838085015(21)530067  (01)00884838085015(21)530071  (01)00884838085015(21)530098  (01)00884838085015(21)530099  (01)00884838085015(21)530101  (01)00884838085015(21)530103  (01)00884838085015(21)530104  (01)00884838085015(21)530106  (01)00884838085015(21)530107  (01)00884838085015(21)530108  (01)00884838085015(21)530109  (01)00884838085015(21)530111  (01)00884838085015(21)530112  (01)00884838085015(21)530113  (01)00884838085015(21)530114  (01)00884838085015(21)530115  (01)00884838085015(21)530116  (01)00884838085015(21)530117  (01)00884838085015(21)530118  (01)00884838085015(21)530119  (01)00884838085015(21)530120  (01)00884838085015(21)530121  (01)00884838085015(21)530124  (01)00884838085015(21)530126  (01)00884838085015(21)530127  (01)00884838085015(21)530128  (01)00884838085015(21)530129  (01)00884838085015(21)530130  (01)00884838085015(21)530132  (01)00884838085015(21)530133 (01)00884838085015(21)530134  (01)00884838085015(21)530135  (01)00884838085015(21)530136  (01)00884838085015(21)530137  (01)00884838085015(21)530138  (01)00884838085015(21)530141  (01)00884838085015(21)530148  (01)00884838085015(21)530150  (01)00884838085015(21)530152  (01)00884838085015(21)530156  (01)00884838085015(21)530157  (01)00884838085015(21)530159  (01)00884838085015(21)530160  (01)00884838085015(21)530163  (01)00884838085015(21)530165  (01)00884838085015(21)530166  (01)00884838085015(21)530167  (01)00884838085015(21)530169  (01)00884838085015(21)530170  (01)00884838085015(21)530171  (01)00884838085015(21)530172  (01)00884838085015(21)530173  (01)00884838085015(21)530174  (01)00884838085015(21)530175  (01)00884838085015(21)530176  (01)00884838085015(21)530177  (01)00884838085015(21)530178  (01)00884838085015(21)530180  (01)00884838085015(21)530181  (01)00884838085015(21)530182  (01)00884838085015(21)530183  (01)00884838085015(21)530186  (01)00884838085015(21)530187  (01)00884838085015(21)530188  (01)00884838085015(21)530189  (01)00884838085015(21)530190  (01)00884838085015(21)530191  (01)00884838085015(21)530192  (01)00884838085015(21)530194  (01)00884838085015(21)530197  (01)00884838085015(21)530198  (01)00884838085015(21)500230

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1273-2021
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1273-2021Class IITerminatedVoluntary: Firm initiated